Drug Information

The Food and Drug Administration (FDA) approved Gammagard Liquid (immune globulin infusion [human], 10% solution, for intravenous and subcutaneous administration) to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). Source: FDA website

The Food and Drug Administration (FDA) approved Xolair® (omalizumab injection for subcutaneous use) for immunoglobulin E-mediated food allergy in certain adults and children 1 year or older for the reduction of allergic reactions (Type I), including reducing the risk of anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjuction with food allergen avoidance. Source: FDA website

The Food and Drug Administration (FDA) approved Tagrisso® (osimertinib tablets) with platinum-based chemotherapy for people with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. Source: FDA website

The Food and Drug Administration (FDA) approved Avycaz® (avibactam sodium/ceftazidime injection for intravenous use) to include the addition of the pediatric population from birth (at least 31 weeks gestational age) to less than 3 months of age for the treatment of complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI), including pyelonephritis, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). Source: FDA website

The Food and Drug Administration (FDA) approved Onivyde® (irinotecan liposome injection for intravenous use) with oxaliplatin, fluorouracil, and leucovorin for the first-line treatment of metastatic pancreatic adenocarcinoma. Source: FDA website

The Food and Drug Administration (FDA) approved Amtagvi (lifileucel suspension for intravenous infusion) for adults with unresectable or metastatic melanoma previously treated with programmed death-1 (PD-1) blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor. Source: FDA website

The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) with chemoradiotherapy (CRT) for people with FIGO 2014 Stage III-IVA cervical cancer. Source: FDA website

The Food and Drug Administration (FDA) approved Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase injection) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults. Source: FDA website

The Food and Drug Administration (FDA) approved CasgevyTM (exagamglogene autotemcel injection) for the treatment of people aged 12 years and older with transfusion-dependent β-thalassemia (TDT). Source: FDA website

The Food and Drug Administration (FDA) approved ZelsuvmiTM (berdazimer topical gel) for the treatment of molluscum contagiosum (MC) in adults and pediatric individuals 1 year of age and older. Source: FDA website

Leiters Health announced a voluntary recall of 33 lots of vancomycin intravenous (IV) bags, phenylephrine IV bags, and fentanyl IV bags due to the potential for superpotency. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/leiters-health-issues-voluntary-nationwide-recall-vancomycin-iv-bags-phenylephrine-iv-bags-and Source: FDA website

The Food and Drug Administration (FDA) has been evaluating reports of suicidal thoughts or actions in people being treated with glucagon-like peptide-1 receptor agonists for type 2 diabetes or obesity. Preliminary evaluations have not found evidence that use of these medications causes suicidal thoughts or actions. The FDA continues to evaluate the issue. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/certain-type-medicines-approved-type-2-diabetes-and-obesity-drug-safety-communication-update-fdas Source: FDA website

The Food and Drug Administration (FDA) approved Piqray® (alpelisib tablets) for expanded use in pre and perimenopausal women for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer. Source: FDA website

The Food and Drug Administration (FDA) approved Zynrelef® (bupivacaine/meloxicam extended-release solution for instillation) to include postsurgical analgesia for up to 72 hours for soft tissue and orthopedic surgical procedures including foot and ankle procedures, and other orthopedic procedures (e.g., total joint arthroplasty) in which direct exposure to articular cartilage is avoided. Source: FDA website

The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) for the treatment of pediatric people aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE). Source: FDA website

Azurity Pharmaceuticals announced a voluntary recall of one lot of Zenzedi® (dextroamphetamine 30 mg tablets) due to a mislabeled package during manufacturing. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/azurity-pharmaceuticals-inc-issues-voluntary-nationwide-recall-zenzedir-dextroamphetamine-sulfate Source: FDA website

The Food and Drug Administration (FDA) has concluded, based on a review of available information, that the osteoporosis medication Prolia® (denosumab injection) increases the risk of severe hypocalcemia, very low blood calcium levels, in people with advanced chronic kidney disease (CKD), especially those on dialysis. Severe hypocalcemia appears to be more common in people with CKD who also have a condition known as mineral and bone disorder (CKD-MBD). The product labeling will be revised. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/prolia-denosumab-drug-safety-communication-fda-adds-boxed-warning-increased-risk-severe-hypocalcemia Source: FDA website

The Food and Drug Administration (FDA) approved Veklury® (remdesivir injection for intravenous use) in pediatric people from birth to less than 28 days of age weighing at least 1.5 kg to less than 3 kg. Source: FDA website.

The Food and Drug Administration (FDA) approved Rybrevant® (amivantamab-vmjw injection for intravenous use) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. Source: FDA website

The Food and Drug Administration (FDA) approved Xofluza® (baloxavir marboxil oral tablets and suspension) for the treatment of pediatric people between the ages of 5 to < 12 years old with acute uncomplicated influenza who are at high risk of developing influenza-related complications. Source: FDA website

The Food and Drug Administration (FDA) approved BesponsaTM (inotuzumab ozogamicin injection for intravenous use) for pediatric people 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). Source: FDA website.

The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection for intravenous use) in combination with cisplatin and gemcitabine for first-line treatment of adults with unresectable or metastatic urothelial carcinoma (UC). Source: FDA website

The Food and Drug Administration (FDA) approved Brukinsa® (zanubrutinib capsules) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Source: FDA website

The Food and Drug Administration (FDA) approved EohiliaTM (budesonide oral suspension) for 12 weeks of treatment in adult and pediatric people 11 years of age and older with eosinophilic esophagitis (EoE). Source: FDA website

The Food and Drug Administration (FDA) approved Clobetasol propionate ophthalmic suspension for the treatment of post-operative inflammation and pain following ocular surgery. Source: FDA website

The Food and Drug Administration (FDA) approved Exblifeb® (cefepime/enmetazobactam injection for intravenous use) for the treatment of people 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible microorganisms. Source: FDA website

The Food and Drug Administration (FDA) approved Praluent® (alirocumab injection for subcutaneous use) as an adjunct to diet and other low-density lipoprotein cholesterol lowering therapies to include pediatric people aged 8 and older with heterozygous familial hypercholesterolemia. Source: FDA website

The Food and Drug Administration (FDA) approved Edurant® (rilpivirine tablets) in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (HIV)-1 infection in treatment naïve pediatric individuals with HIV-1 ribonucleic acid (RNA) less than or equal to 100,000 copies/mL who are 2 years of age and older and weigh at least 14 kg to less than 25 kg. A new 2.5 mg tablet for oral suspension was also approved. Source: FDA website

The Food and Drug Administration (FDA) approved Spevigo® (spesolimab-sbzo injection for subcutaneous or intravenous use) to include the treatment of generalized pustular psoriasis (GPP) in adult and pediatric individuals 12 years of age and older and weighing at least 40 kg. Source: FDA website

The Food and Drug Administration (FDA) approved Wegovy® (semaglutide injection for subcutaneous use) for use in combination with a reduced calorie diet and increased physical activity to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal heart attack, or non-fatal stroke) in adults with established CV disease and either obesity or overweight. Source: FDA website

The Food and Drug Administration (FDA) approved Livmarli® (maralixibat oral solution) for the treatment of cholestatic pruritus in people 5 years of age and older with progressive familial intrahepatic cholestasis (PFIC). Source: FDA website

The Food and Drug Administration (FDA) approved Breyanzi® (lisocabtagene maraleucel suspension for intravenous infusion) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. Source: FDA website

The Food and Drug Administration (FDA) approved Xhance® (fluticasone propionate nasal spray) for the treatment of chronic rhinosinusitis without nasal polyps in people 18 years of age and older. Source: FDA website

The Food and Drug Administration (FDA) approved Iclusig® (ponatinib tablets) with chemotherapy for adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Source: FDA website

The Food and Drug Administration (FDA) approved TevimbraTM (tislelizumab-jsgr injection for intravenous use) for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a programmed death receptor-1 (PD-1) or PD-ligand 1 (PD-L1) inhibitor. Source: FDA website

The Food and Drug Administration (FDA) approved LenmeldyTM (atidarsagene autotemcel suspension for intravenous infusion) for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ) metachromatic leukodystrophy (MLD). Source: FDA website

The Food and Drug Administration (FDA) approved TryvioTM (aprocitentan tablets) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adults who are not adequately controlled on other drugs. Source: FDA website

The Food and Drug Administration (FDA) approved DuvyzatTM (givinostat oral suspension) for the treatment of Duchenne muscular dystrophy (DMD) in individuals 6 years of age and older. Source: FDA website

The Food and Drug Administration (FDA) approved RezdiffraTM (resmetirom tablets) for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Indicated in conjunction with diet and exercise. Source: FDA website

Endo International announced a voluntary recall of one lot of treprostinil injection 20 mg/20 mL due to the potential for silicone particulates. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/par-pharmaceutical-issues-voluntary-nationwide-recall-one-lot-treprostinil-injection-due-potential Source: FDA website

The Food and Drug Administration (FDA) approved Ixinity® (coagulation factor IX, recombinant, injection) for the on-demand, prophylactic, and perioperative treatment of pediatric individuals under 12 years of age with hemophilia B. Source: FDA website

The Food and Drug Administration (FDA) approved Nexletol® (bempedoic acid tablets) and Nexlizet® (bempedoic acid/ezetimibe tablets) to reduce risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with: • established cardiovascular disease (CVD), or • a high risk for a CVD event but without established CVD. Source: FDA website

The Food and Drug Administration (FDA) approved Vemlidy® (tenofovir alafenamide tablets) for the once-daily treatment of chronic hepatitis B virus or HBV infection in pediatric individuals aged six years and older, weighing at least 25 kg, with compensated liver disease. Source: FDA website

The Food and Drug Administration (FDA) approved Abecma® (idecabtagene vicleucel injection) for the treatment of adults with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Source: FDA website

The Food and Drug Administration (FDA) approved CarvyktiTM (ciltacabtagene autoleucel) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. Source: FDA website

The Food and Drug Administration (FDA) approved Dovato (dolutegravir/lamivudine tablets) for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato. Source: FDA website

The Food and Drug Administration (FDA) approved Fasenra® (benralizumab) as add-on maintenance treatment of individuals aged 6 to 11 years with severe asthma, and with an eosinophilic phenotype. Source: FDA website

The Food and Drug Administration (FDA) approved Ultomiris® (ravulizumab-cwvz injection) for the treatment of adults with AQP4 antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). Source: FDA website

The Food and Drug Administration (FDA) approved Fanapt® (iloperidone tablets) for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Source: FDA website

The Food and Drug Administration (FDA) approved Enhertu® (fam-trastuzumab deruxtecan-nxki injection) for adults with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. Source: FDA website

The Food and Drug Administration (FDA) approved Opsynvi® (macitentan/tadalafil tablets) for chronic treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults of WHO functional class (FC) II-III. Source: FDA website

The Food and Drug Administration (FDA) approved Risvan® (risperidone extended-release injection) for the treatment of schizophrenia in adults. Source: FDA website

The Food and Drug Administration (FDA) approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections (ABSSSI); and adult and pediatric individuals three months to less than 18 years old with community-acquired bacterial pneumonia (CABP). Source: FDA website

The Food and Drug Administration (FDA) approved WinrevairTM (sotatercept-csrk injection) for the treatment of adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve World Health Organization (WHO) functional class (FC) and reduce the risk of clinical worsening events. Source: FDA website

The Food and Drug Administration (FDA) approved Vafseo® (vadadustat tablets) for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least 3 months. Source: FDA website

The Food and Drug Administration (FDA) approved VoydeyaTM (danicopan taglets) as add-on therapy to Soliris® (eculizumab injection) or Ultomiris® (ravulizumab-cwvz injection) for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). Source: FDA website

AvKARE announced a voluntary recall of one lot of atovaquone 750 mg/5 mL oral suspension due to potential Bacillus cereus contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avkare-llc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5-ml-due Source: FDA website

Eugia US announced a voluntary recall of one lot of methocarbamol injection 1000 mg/10 mL single dose vial due to presence of white particles. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eugia-us-llc-fka-auromedics-pharma-llc-issues-voluntary-nationwide-recall-methocarbamol-injection Source: FDA website

Amneal Pharmaceuticals announced a voluntary recall of 4 lots of vancomycin hydrochloride for oral solutoin 250 mg/5 mL due to the potential for some bottles to be super potent which may be harmful. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-nationwide-voluntary-recall-vancomycin-hydrochloride-oral-solution Source: FDA website

The Food and Drug Administration (FDA) approved Entyvio® (vedolizumab subcutaneous injection) in adults for the treatment of moderately-to-severely active Crohn’s disease. Source: FDA website

The Food and Drug Administration (FDA) approved Rinvoq® (upadacitinib extended-release tablets) for the treatment of individuals 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one of more tumor necrosis factor (TNF) blockers, and the treatment of individuals 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers, respectively. An oral solution formulation was also approved. Source: FDA website

The Food and Drug Administration (FDA) approved Lutathera® (lutetium Lu 177 dotatate injection for intravenous use) for pediatric individuals 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. Source: FDA website

The Food and Drug Administration (FDA) approved Otezla® (apremilast tablets) for the treatment of pediatric individuals 6 to 17 years of age and weighing at least 20kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Source: FDA website

The Food and Drug Administration (FDA) approved Alecensa® (alectinib capsules) for adjuvant treatment following tumor resection in individuals with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.Source: FDA website

The Food and Drug Administration (FDA) approved Alecensa® (alectinib capsules) for adjuvant treatment following tumor resection in individuals with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.Source: FDA website

The Food and Drug Administration (FDA) approved Mircera® (methoxy polyethylene glycol-epoetin beta injection for intravenous or subcutaneous use) for expanded use in the treatment of anemia associated with chronic kidney disease (CKD) in pediatric individuals 3 months to 17 years of age on dialysis and not on dialysis who are converting from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA. This approval also allows for a subcutaneous route of administration in pediatrics. Source: FDA website

The Food and Drug Administration (FDA) approved Myhibbin (mycophenolate mofetil oral suspension) for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. Source: FDA website

The Food and Drug Administration (FDA) approved Xromi (hydroxyurea oral solution) to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric individuals aged 6 months of age to less than 2 years with sickle cell anemia with recurrent moderate to severe painful crises. Source: FDA website

The Food and Drug Administration (FDA) approved Ingrezza® Sprinkle (valbenazine capsules) for the treatment of tardive dyskinesia and Huntington’s chorea. Source: FDA website

The Food and Drug Administration (FDA) approved Rezenopy (naloxone nasal spray) for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adults and pediatric individuals, and is intended for immediate administration as emergency therapy in settings where opioids may be present. Source: FDA website

The Food and Drug Administration (FDA) approved Vijoice® (alpelisib oral granules) for the treatment of adult and pediatric individuals 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. Source: FDA website

The Food and Drug Administration (FDA) approved LibervantTM (diazepam buccal film) for the treatment of seizure clusters in individuals ages 2 to 5 years. Source: FDA website

The Food and Drug Administration (FDA) approved Anktiva® (nogapendekin alfa inbakicept-pmln solution for intravesical use) with Bacillus Calmette-Guérin (BCG) for the treatment of adults with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors. Source: FDA website

The Food and Drug Administration (FDA) approved OjemdaTM (tovorafenib tablets and suspension for oral use) for the treatment of individuals 6 months of age and older with relapsed or refractory pediatric low grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. Source: FDA website

The Food and Drug Administration (FDA) approved PivyaTM (pivmecillinam tablets) for the treatment of females 18 years of age and older with uncomplicated urinary tract infections (uUTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. Source: FDA website

The Food and Drug Administration (FDA) approved BeqvezTM (fidanacogene elaparvovec-dzkt injection for intravenous infusion) for the treatment of adults with moderate-to-severe hemophilia B (congenital Factor IX deficiency) who:
• Currently use Factor IX prophylaxis therapy, or
• Have current or historical life-threatening hemorrhage, or
• Have repeated, serious spontaneous bleeding episodes, and
• Do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by a FDA-approved test. Source: FDA website

The Food and Drug Administration (FDA) approved XolremdiTM (mavorixafor capsules) for individuals 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes. Source: FDA website

Dr. Reddy’s Laboratories announced a voluntary recall of 6 lots of sapropterin dihydrochloride powder for oral solution 100 mg due to sub-potency. Contact your healthcare provdier with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-issues-voluntary-nationwide-recall-sapropterin-dihydrochloride-powder-oral-solution-100-mg Source: FDA website

The Food and Drug Administration (FDA) approved Breyanzi® (lisocabtagene maraleucel injection) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. Source: FDA website

The Food and Drug Administration (FDA) approved Breyanzi® (lisocabtagene maraleucel injection) for adults with relapsed or refractory (R/R) mantle cell lymphoma (MCL) who were previously administered at least two lines of systemic therapy that included a Bruton tyrosine kinase (BTK) inhibitor. Source: FDA website

The Food and Drug Administration (FDA) approved RetevmoTM (selpercatinib capsules and tablets) for pediatric individuals two years of age and older with the following:
• advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy;
• advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate); and
• locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.Source: FDA website

The Food and Drug Administration (FDA) approved OnydaTM XR (clonidine hydrochloride extended-release suspension) for the treatment of attention-deficit/hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medication. Source: FDA website

The Food and Drug Administration (FDA) approved Benlysta (belimumab 200 mg autoinjector) for children aged 5 years and older with systemic lupus erythematosus (SLE) to allow for at-home administration. Source: FDA website

The Food and Drug Administration (FDA) approved ImdelltraTM (tarlatamab-dlle injection) for the treatment of adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Source: FDA website

The Food and Drug Administration (FDA) approved mResviaTM (respiratory syncytial virus vaccine intramuscular injection) for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. Source: FDA website

Hospira announced a voluntary recall of certain lots of buprenorphine hydrochloride injection CarpujectTM units and labetalol hydrochloride injection CarpujectTM units due to the potential for incomplete crimp seals. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-buprenorphine-hydrochloride-injection-carpujecttm Source: FDA website

Sagent Pharmaceuticals announced a voluntary recall of two lots of docetaxel injection (80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials) due to potential presence of particulate matter from the stopper in the drug product. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-issues-voluntary-nationwide-recall-docetaxel-injection-usp-due-potential Source: FDA website

The Food and Drug Administration (FDA) is alerting healthcare providers and consumers of labeling updates for glatiramer acetate injection products. The updated labeling includes a new warning that using an autoinjector that is not compatible with a specific glatiramer acetate injection may increase the risk of medication errors. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-caregivers-and-health-care-providers-cross-compatibility-issues-autoinjector Source: FDA website

The Food and Drug Administration (FDA) approved EpkinlyTM (epcoritamab-bysp injection) for adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Source: FDA website

The Food and Drug Administration (FDA) approved ZoryveTM (roflumilast topical cream) for the treatment of mild to moderate atopic dermatitis in adult and pediatric individuals 6 years of age and older. Source: FDA website

The Food and Drug Administration (FDA) approved Voquezna® (vonoprazan tablets) for the relief of heartburn associated with nonerosive gastroesophageal reflux disease (GERD) in adults. Source: FDA website

The Food and Drug Administration (FDA) approved Velphoro® (ferric oxyhydroxide chewable tables) for the control of serum phosphorus levels in adult and pediatric individuals 9 years of age and older with chronic kidney disease on dialysis. Source: FDA website

The Food and Drug Administration (FDA) approved Xeomin® (incobotulinumtoxinA intramuscular or intraglandular injection) for the temporary improvement of the appearance of upper facial lines in adults. Source: FDA website

The Food and Drug Administration (FDA) approved Tepylute (thiotepa injection) for the treatment of adenocarcinoma of the breast or ovary. Source: FDA website

The Food and Drug Administration (FDA) approved Chewtadzy (tadalafil chewable tablet) for the treatment of erectile dysfunction (ED), benign prostatic hyperplasia (BPH), and ED plus BPH. Source: FDA website

The Food and Drug Administration (FDA) approved VabysmoTM (faricimab-svoa 6.0 mg single-dose prefilled syringe for intravitreal injection) for use in the treatment of neovascular or wet age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Source: FDA website

The Food and Drug Administration (FDA) approved OhtuvayreTM (ensifentrine oral inhalation using a standard jet nebulizer) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. Source: FDA website

The Food and Drug Administration (FDA) approved KisunlaTM (donanemab-azbt injection) for the treatment of Alzheimer’s disease. Treatment should be initiated in individuals with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials. Source: FDA website

Endo announced a voluntary recall of one lot of clonazepam orally disintegrating tablets due to mislabeling. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-one-lot-clonazepam-orally-disintegrating-tablets-usp. Source: FDA website

American Health Packaging on behalf of BluePoint Laboratories announced a voluntary recall of 21 batches of potassium chloride extended-release capsules 750 mg due to failed dissolution. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-health-packaging-behalf-bluepoint-laboratories-issues-voluntary-nationwide-recall-potassium Source: FDA website

Glenmark Pharmaceuticals announced a voluntary recall of 114 batches of potassium chloride extended-release capsules 750 mg due to failed dissolution. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/glenmark-pharmaceuticals-inc-usa-issues-voluntary-nationwide-recall-potassium-chloride-extended Source: FDA website

Hikma Pharmaceuticals is extending its recall of one lot of acetaminophen injection 1000 mg/100 mL due to the potential presence of a bag labeled dexmedetomidine HCl injection 400 mcg/100 mL inside the overwrap. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hikma-pharmaceuticals-usa-inc-extends-voluntary-nationwide-recall-one-lot-acetaminophen-injection Source: FDA website

The Food and Drug Administration (FDA) approved Brineura® (cerliponase alfa injection) expanson to slow the loss of ambulation in children of all ages with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency. Source: FDA website

The Food and Drug Administration (FDA) approved Livmarli® (maralixibat oral solution) to include treatment of cholestatic pruritus in individuals 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC). A high concentration formulation was also approved. Source: FDA website

The Food and Drug Administration (FDA) approved Xembify® (immune globulin subcutaneous human-klhw injection) to include biweekly dosing and use in treatment-naive individuals for primary immunodeficiency. Source: FDA website

The Food and Drug Administration (FDA) approved Palforzia® (peanut allergen powder-dnfp) to include initiation of treatment, up-dosing and maintenance in individuals ages 1 through 3 years with a confirmed diagnosis of peanut allergy to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. Source: FDA website

The Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj injection) in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in individuals with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). Source: FDA website

The Food and Drug Administration (FDA) approved Jemperli (dostarlimab-gxly injection) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adults with primary advanced or recurrent endometrial cancer (EC). Source: FDA website

The Food and Drug Administration (FDA) approved TofidenceTM (tocilizumab-bavi injection) for adults with giant cell arteritis (GCA) and hospitalized adults with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Source: FDA website

The Food and Drug Administration (FDA) approved Femlyv (norethindrone acetate and ethinyl estradiol orally disintegrating tablets) for the prevention of pregnancy. Source: FDA website

The Food and Drug Administration (FDA) approved Zituvimet XR (sitagliptin/metformin hydrochloride extended-release tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Source: FDA website

The Food and Drug Administration (FDA) approved Erzofri® (paliperidone palmitate extended-release injectable suspension for intramuscular injection) for the treatment of schizophrenia in adults. Source: FDA website

The Food and Drug Administration (FDA) approved Tezruly (terazosin oral solution) for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) and the treatment of hypertension alone or with other antihypertensive agents. Source: FDA website

The Food and Drug Administration (FDA) approved Zunveyl® (benzgalantamine delayed release tablets) for the treatment of mild-to-moderate dementia in adults. Source: FDA website

The Food and Drug Administration (FDA) approved LeqselviTM (deuruxolitinib tablets) for the treatment of adults with severe alopecia areata. Source: FDA website

The Food and Drug Administration (FDA) approved Fabhalta® (iptacopan capsules) for the reduction of proteinuria in primary IgA nephropathy (IgAN). Source: FDA website

The Food and Drug Administration (FDA) approved expanded use of Furoscix® (furosemide injection for subcutaneous use) to include treatment of congestion due to fluid overload in adults with chronic heart failure (CHF), regardless of New York Heart Association (NYHA) functional class. Source: FDA website

The Food and Drug Administration (FDA) approved Protonix® I.V. (pantoprazole sodium injection for intravenous use) for the treatment of gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 7 days in pediatric individuals 3 months and older.

The Food and Drug Administration (FDA) approved NexoBrid® (anacaulase-bcdb topical gel) for eschar removal in pediatric individuals with deep partial-thickness and/or full-thickness thermal burns. Source: FDA website

The Food and Drug Administration (FDA) approved Imfinzi® (durvalumab injection for intravenous use) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. Source: FDA website

The Food and Drug Administration (FDA) approved CrexontTM (carbidopa/levodapa extended-release capsules) for the treatment of Parkinson’s disease (PD). Source: FDA website

The Food and Drug Administration (FDA) approved Zurnai® (nalmefene hydrochloride auto-injector for intramuscular or subcutaneous use) for the emergency treatment of known or suspected opioid overdose in adults and pediatric individuals 12 years of age and older. Source: FDA website

The Food and Drug Administration (FDA) approved LymphirTM (denileukin diftitox-cxd injection for intravenous use) for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy. Source: FDA website

The Food and Drug Administration (FDA) approved Neffy® (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), in adult and pediatric individuals who weigh at least 30 kilograms (about 66 pounds). Source: FDA website

The Food and Drug Administration (FDA) approved Tecelra® (afamitresgene autoleucel suspension for intravenous infusion) for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are Human Leukocyte Antigen (HLA)-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the melanoma-associated antigen A4 (MAGE-A4) as determined by FDA-approved or cleared companion diagnostic devices. Source: FDA website

The Food and Drug Administration (FDA) approved Yorvipath® (palopegteriparatide injection for subcutaneous use) for the treatment of hypoparathyroidism in adults. Source: FDA website

The Food and Drug Administration (FDA) approved Nemluvio® (nemolizumab-ilto for injection for subcutaneous use) for the treatment of adults with prurigo nodularis (PN). Source: FDA website

The Food and Drug Administration (FDA) approved Livdelzi® (seladelpar capsules) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA; ursodiol) in adults who have an inadequate response to UDCA, or as monotherapy in individuals unable to tolerate UDCA. Source: FDA website

The Food and Drug Administration (FDA) approved LymphirTM (axatilimab-csfr injection for intravenous use) for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric individuals weighing at least 40 kg. Source: FDA website

The Food and Drug Administration (FDA) approved Voranigo® (vorasidenib tablets) for the treatment of adults and pediatrics 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection. Source: FDA website

Baxter announced a voluntary recall of one lot of heparin sodium in 0.9% sodium chloride injection due to potential for elevated endotoxin levels. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-voluntary-nationwide-recall-one-lot-heparin-sodium-09-sodium-chloride-injection-due Source: FDA website

B. Braun Medical announced a voluntary recall of two lots of 0.9% sodium chloride for injection 1000 mL in E3 containers due to the potential for particulate matter and leakage. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-issues-voluntary-nationwide-recall-09-sodium-chloride-injection-usp-1000-ml-e3-containers Source: FDA website

The Food and Drug Administration (FDA) approved ACAM2000® (smallpox and mpox vaccine, live suspension, for percutaneous use) to include prevention of mpox disease in individuals determined to be at high risk for mpox infection. Source: FDA website

The Food and Drug Administration (FDA) approved Tremfya® (guselkumab injection) to treat moderate-to-severe active ulcerative colitis (UC) in adults. Source: FDA website

The Food and Drug Administration (FDA) approved Prevymis® (letermovir tablets, injection, and oral pellets) to expand use to include pediatric hematopoietic stem cell transplant recipients 6 months of age and older and weighing at least 6 kg and pediatric kidney transplant recipients 12 years of age and older and weighing at least 40 kg. An oral pellet formulation was also approved. Source: FDA website

The Food and Drug Administration (FDA) approved Dupixent® (dupilumab subcutaneous injection) to include add-on maintenance treatment of adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). Source: FDA website

The Food and Drug Administration (FDA) approved BoruzuTM (bortezomib ready-to-use subcutaneous injection) for the treatment of adults with multiple myeloma and for the treatment of adults with mantle cell lymphoma. Source: FDA website

The Food and Drug Administration (FDA) approved Tecentriq HybrezaTM (atezolizumab and hyaluronidase-tqjs subcutaneous injection) for all the adult indications as the intravenous formulation including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS). Source: FDA website

The Food and Drug Administration (FDA) approved Ocrevus ZunovoTM (ocrelizumab & hyaluronidase-ocsq subcutaneous injection) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Source: FDA

The Food and Drug Administration (FDA) approved LazcluzeTM (lazertinib tablets) in combination with Rybrevant (amivantamab-vmjw injection) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. Source: FDA website

The Food and Drug Administration (FDA) approved Ebglyss (lebrikizumab subcutaneous injection) for the treatment of adults and children age 12 years and older who have moderate-to-severe atopic dermatitis (AD) that is not well controlled, despite treatment with topical prescription therapies. Source: FDA website

The Food and Drug Administration (FDA) issued a warning that Veozah® (fezolinetant tablets), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. The FDA has added a warning about this risk to the existing warning about elevated liver function test values and required liver function testing in the prescribing information. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due Source: FDA website

The Food and Drug Administration (FDA) approved Cimzia® (certolizumab pegol injection) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) for individuals 2 years of age and older. Source: FDA website

The Food and Drug Administration (FDA) approved Kisqali® (ribociclib tablets) with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. The Food and Drug Administration (FDA) also approved the Kisqali Femara® Co-Pack (ribociclib and letrozole) for the same indication. Source: FDA website

The Food and Drug Administration (FDA) approved Rybrevant® (amivantamab-vmjw injection) with carboplatin and pemetrexed for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. Source: FDA website

The Food and Drug Administration (FDA) approved Sarclisa® (isatuximab-irfc injection) for use with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). Source: FDA website

The Food and Drug Administration (FDA) approved Flumist® (influenza vaccine live intranasal) for self- or caregiver-administration for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age. Source: FDA website

The Food and Drug Administration (FDA) approved Tagrisso® (osimertinib tablets) for adults with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by a Food and Drug Administration (FDA)-approved test. Source: FDA website

The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. Source: FDA website

The Food and Drug Administration (FDA) approved Fasenra® (benralizumab injection) to treat adults with eosinophilic granulomatosis with polyangiitis (EGPA), a type of rare immune-mediated vasculitis. Source: FDA website

The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM). Source: FDA website

The Food and Drug Administration (FDA) approved Bimzelx® (bimekizumab-bkzx injection) for adults with active psoriatic arthritis (PsA), active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS). Source: FDA website

The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) as add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Source: FDA website

The Food and Drug Administration (FDA) approved Bynfezia Pen® (octreotide subcutaneous injection) for acromegaly, carcinoid tumors, and vasoactive intestinal peptide tumors. Source: FDA website

The Food and Drug Administration (FDA) approved AqneursaTM (levacetylleucine for oral suspension) for the treatment of neurological manifestations of Niemann-Pick Disease Type C (NPC) in individuals weighing 15 kg or more. Source: FDA website

The Food and Drug Administration (FDA) approved MiplyffaTM (arimoclomol capsules) in combination with miglustat oral for the treatment of neurological manifestations of Niemann-Pick Disease Type C (NPC) in individuals 2 years and older. Source: FDA website

The Food and Drug Administration (FDA) approved CobenfyTM (xanomeline and trospium chloride) for the treatment of schizophrenia in adults. Source: FDA website

BionPharma announced a voluntary recall of one batch of atovaquone oral suspension 750 mg per mL due to bacterial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bionpharma-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-due-bacterial Source: FDA website

Gilead Sciences announced a voluntary recall of one lot of Veklury® (remdesivir) for injection 100 mg/vial due to the presence of a glass particle. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gilead-issues-voluntary-nationwide-recall-one-lot-veklury-remdesivir-injection-100-mgvial-due Source: FDA website

The Food and Drug Administration (FDA) approved LumryzTM (sodium oxybate extended-release oral suspension) to include treatment of cataplexy or excessive daytime sleepiness (EDS) in adults 7 years of age and older with narcolepsy. Source: FDA website

The Food and Drug Administration (FDA) approved Abrysvo® (respiratory syncytial virus vaccine intramuscular injection) to include active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Source: FDA website

The Food and Drug Administration (FDA) approved Bimzelx® (bimekizumab-bkzx subcutaneous injection) for adults with active psoriatic arthritis (PsA), active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS). Source: FDA website

The Food and Drug Administration (FDA) approved Jylamvo (methotrexate oral solution) for the treatment of pediatric individuals with polyarticular juvenile idiopathic arthritis (pJIA) and for the treatment of pediatric individuals with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. Source: FDA website

The Food and Drug Administration (FDA) approved Scemblix® (asciminib tablets) for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). Source: FDA website

The Food and Drug Administration (FDA) approved VyalevTM (foscarbidopa/foslevodopa injection for subcutaneous use) for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. Source: FDA website

The Food and Drug Administration (FDA) approved ItovebiTM (inavolisib tablets) for use in combination with Ibrance® (palbociclib tabets and capsules) and fulvestrant to treat adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer following recurrence on or after completing adjuvant endocrine therapy. Source: FDA website

The Food and Drug Administration (FDA) approved HympavziTM (marstacimab-hncq injection for subcutaneous use) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatrics 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors. Source: FDA website

The Food and Drug Administration (FDA) approved VyloyTM (zolbetuximab-clzb injection for intravenous use) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. Source: FDA website

The Food and Drug Administration (FDA) approved OrlynvahTM (sulopenem etzadroxil and probenecid tablets) for the treatment of uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. Source: FDA website

Staska Pharmaceuticals announced a voluntary recall of one lot of ascorbic acid solution for injection due to the presence of glass particulates. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/staska-pharmaceuticals-inc-issues-voluntary-nationwide-recall-ascorbic-acid-solution-injection Source: FDA website

The Food and Drug Administration (FDA) approved EmrosiTM (minocycline hydrochloride extended-release capsules) for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults. Source: FDA website

The Food and Drug Administration (FDA) approved DanzitenTM (nilotinib tartrate tablets) for the treatment of adults with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Also approved for the treatment of adults with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included imatinib. Source: FDA website

The Food and Drug Administration (FDA) approved Aucatzyl® (obecabtagene autoleucel suspension for intravenous infusion) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Source: FDA website

The Food and Drug Administration (FDA) approved Kebilidi (eladocagene exuparvovec-tneq suspension for intraputaminal infusion) for the treatment of adult and pediatric individuals with aromatic L-amino acid decarboxylase (AADC) deficiency. Source: FDA website

The Food and Drug Administration (FDA) is warning consumers and health care providers not to use drugs compounded and distributed by Fullerton Wellness LLC in Ontario, California due to sterility issues. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-patients-and-health-care-professionals-not-use-compounded-drugs-fullerton-wellness Source: FDA website

The Food and Drug Administration (FDA) approved Bimzelx® (bimekizumab injection) to treat active moderate-to-severe hidradenitis suppurativa (HS) in adults responding inadequately to conventional systemic therapy. Source: FDA website

The Food and Drug Administration (FDA) approved Imfinzi® (durvalumab injection) for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Source: FDA website

The Food and Drug Administration (FDA) approved Imkeldi (imatinib oral solution) to treat chronic myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic/myeloproliferative diseases, and gastrointestinal stromal tumors as well as aggressive systematic mastocytosis, hypereosinophilic syndrome, chronic eosinophilic leukemia, and dermatofibrosarcoma protuberans. Source: FDA website

The Food and Drug Administration (FDA) approved Rapiblyk (landiolol injection) for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter. Source: FDA website

The Food and Drug Administration (FDA) approved Attruby® (acoramidis tablets) for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. Source: FDA website

The Food and Drug Administration (FDA) approved Ziihera® (zanidatamab-hrii injection) for the treatment of adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer. Source: FDA website

The Food and Drug Administration (FDA) approved Revuforj® (revumenib tablets) for relapsed or refractory acute leukemia lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric individuals aged 1 year and older. Source: FDA website

The Food and Drug Administration (FDA) approved Bizengri® (zenocutuzumab-zbco injection) for adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. Source: FDA website

Endo is expanding a previously announced voluntary recall of clonazepam orally disintegrating tablets due to potential product carton strength mislabeling. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-expands-voluntary-recall-clonazepam-orally-disintegrating-tablets-usp-c-iv-due-potential Source: FDA website

The Food and Drug Administration (FDA) identified cases of serious liver injury among individuals being treated for primary biliary cholangitis (PBC) with Ocaliva® (obeticholic acid tablets) who did not have liver cirrhosis. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/ocaliva-obeticholic-acid-intercept-pharmaceuticals-drug-safety-communication-serious-liver-injury?utm_medium=email&utm_source=govdelivery Source: FDA website

The Food and Drug Administration (FDA) approved Vtama® (tapinarof topical cream) for the treatment of atopic dermatitis (AD) in adults and pediatric individuals 2 years of age and older. Source: FDA website

The Food and Drug Administration (FDA) approved Nemluvio® (nemolizumab injection) for the treatment of individuals 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies. Source: FDA website

The Food and Drug Administration (FDA) approved Gemtesa® (vibegron tablets) for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). Source: FDA website

The Food and Drug Administration (FDA) approved Invokana® (canagliflozin tablets), Invokamet® (canagliflozin/metformin tablets), and Invokamet® XR (canagliflozin/metformin extended-release) as an adjunct to diet and exercise to improve glycemic control in pediatric individuals aged 10 years and older. Source: FDA website

The Food and Drug Administration (FDA) approved Braftovi® (encorafenib capsules) with cetuximab and mFOLFOX6 for individuals with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by a FDA-approved test. Source: FDA website

The Food and Drug Administration (FDA) approved Zepbound® (tirzepatide injection) in combination with a reduced-calorie diet and increased physical activity to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. Source: FDA website

The Food and Drug Administration (FDA) approved Tevimbra® (tislelizumab-jsgr injection) for use in combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) whose tumors express programmed death-ligand 1 (PD-L1) ≥1. Source: FDA website

The Food and Drug Administration (FDA) approved Imcivree® (setmelanotide injection) to include children as young as 2 years old with obesity due to Bardet-Biedl syndrome (BBS) or pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. Source: FDA website

The Food and Drug Administration (FDA) approved Trikafta® (elexacaftor/tezacaftor/ivacaftor tablets and oral granules) for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation that is responsive to Trikafta based on clinical and/or in vitro data. With this approval, 94 additional non-F508del CFTR mutations have been added to the Trikafta label. Source: FDA website

The Food and Drug Administration (FDA) approved Xromi (hydroxyurea oral solution) to reduce the frequency of painful crises and to reduce the need for blood transfusions in pediatric individuals 2 years of age and older with sickle cell anemia with recurrent moderate to severe painful crises. Source: FDA website

The Food and Drug Administration (FDA) approved Arixtra (fondaparinux sodium injection) for the treatment of venous thromboembolism in pediatric individuals aged 1 year or older weighing at least 10 kg. Source: FDA website

The Food and Drug Administration (FDA) approved UnloxcytTM (cosibelimab-ipdl injection for intravenous use) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. Source: FDA website

The Food and Drug Administration (FDA) approved CrenessityTM (crinecerfont capsules and oral solution) as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric individuals 4 years of age and older with classic congenital adrenal hyperplasia (CAH). Source: FDA website

The Food and Drug Administration (FDA) approved EnsacoveTM (ensartinib capsules) for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor. Source: FDA website

The Food and Drug Administration (FDA) approved Tryngolza (olezarsen subcutaneous injection) as adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). Source: FDA website

The Food and Drug Administration (FDA) approved Alhemo® (concizumab-mtci subcutaneous injection) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric individuals 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors. Source: FDA website

The Food and Drug Administration (FDA) approved Alyftrek (vanzacaftor/ tezacaftor/ deutivacaftor tablets) for the treatment of cystic fibrosis (CF) in individuals aged 6 years and older who have at least one F508del mutation or another responsive mutation in the CFTR gene. Source: FDA website

The Food and Drug Administration (FDA) approved Opdivo QvantigTM (nivolumab and hyaluronidase-nvhy subcutaneous injection) for renal cell carcinoma, melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal carcinoma, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Source: FDA website

The Food and Drug Admistration (FDA) added a Boxed Warning to the Veozah labeling to highlight the risk of rare but serious liver injury associated with use. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due Source: FDA website

Astellas Pharma announced a voluntary recall of one lot of Prograf 0.5 mg (tacrolimus) and one lot of Astagraf XL 0.5 mg (tacrolimus extended-release) because bottles may contain empty capsules. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/astellas-pharma-us-inc-issues-voluntary-nationwide-recall-one-lot-prografr-05mg-tacrolimus-and-one Source: FDA website

The Food and Drug Administration (FDA) has approved labeling changes for AbrysvoTM (respiratory syncytial virus vaccine intramuscular injection) and Arexvy (respiratory syncytial virus vaccine, adjuvanted intramuscular injection) to include a warning about the risk for Guillain-Barré syndrome (GBS). Contact your healthcare provider. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and Source: FDA website

The Food and Drug Administration (FDA) approved Enhertu® (fam-trastuzumab deruxtecan-nxki injection for intravenous use) for the treatment of adults with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer that has progressed on one or more endocrine therapies in the metastatic setting. Source: FDA website

The Food and Drug Administration (FDA) approved SusvimoTM (ranibizumab injection for ocular implant) for the treatment of diabetic macular edema (DME). Source: FDA website

The Food and Drug Administration (FDA) approved Ozempic® (semaglutide injection for subcutaneous use) to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease. Source: FDA website

The Food and Drug Administration (FDA) approved Symbravo (meloxicam/rizatriptan oral tablets) for acute migraine treatment with or without aura. Source: FDA website

The Food and Drug Administration (FDA) approved OnapgoTM (apomorphine hydrochloride subcutaneous infusion device) for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. Sourc: FDA website

The Food and Drug Administration (FDA) approved JournavxTM (suzetrigine oral tablets) to treat moderate-to-severe acute pain in adults. Source: FDA website

Provepharm Inc. announced a voluntary recall of one lot of phenylephrine hydrochloride injection 10 mg/mL due to the presence of particulate matter. Contact your healthcare provider with questions. More details may be available at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/provepharm-inc-issues-voluntary-nationwide-recall-one-lot-phenylephrine-hydrochloride-injection-usp Source: FDA website

Alvogen announced a voluntary recall of one lot of fentanyl transdermal system 25 mcg/h due to a defective delivery system. Contact your healthcare provider with questions. More details may be available at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alvogen-issues-voluntary-nationwide-recall-one-lot-fentanyl-transdermal-system-25-mcgh-due-defective Source: FDA website

The Food and Drug Administration (FDA) approved Adcetris® (brentuximab vedotin injection for intravenous use) in combination with lenalidomide and a rituximab product for adults with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy. Source: FDA website

The Food and Drug Administration (FDA) approved Odefsey® (emtricitabine/rilpivirine/tenofovir alafenamide tablets) label expansion to include pediatric individuals weighing at least 25 kg to less than 35 kg for the treatment of human immunodeficiency virus-1 (HIV-1) infection as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL and pediatric individuals weighing at least 25 to less than 35 kg for the treatment of HIV-1 infection to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL). Source: FDA website

The Food and Drug Administration (FDA) approved Evrysdi® (risdiplam tablets) 5 mg tablet formulation for the treatment of spinal muscular atrophy (SMA) in individuals 2 years of age and older weighing at least 20 kg. Source: FDA website

The Food and Drug Administration (FDA) approved Emblaveo (aztreonam/avibactam injection for intravenous use) in combination with metronidazole for individuals 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI), including those caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Source: FDA website

The Food and Drug Administration (FDA) approved VimkunyaTM (chikungunya vaccine, recombinant injection for intramuscular use) for the prevention of disease caused by chikungunya virus in individuals 12 years of age and older. Source: FDA website

The Food and Drug Administration (FDA) approved Penmenvy (meningococcal groups A, B, C, W, and Y vaccine injection for intramuscular use) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals 10 through 25 years of age. Source: FDA website

The Food and Drug Administration (FDA) approved RomvimzaTM (vimseltinib capsules) for the treatment of adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. Source: FDA website

The Food and Drug Administration (FDA) approved GomekliTM (mirdametinib capsules and tablets for oral suspension) for adult and pediatric individuals 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. Source: FDA website

ICU Medical announced a voluntary recall of one lot each of potassium chloride injection 20 mEq and potassium chloride injection 10 mEq due to mislabeling. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/icu-medical-issues-nationwide-recall-potassium-chloride-injection-20-meq-and-potassium-chloride Source: FDA website

The Food and Drug Administration (FDA) approved Odactra® (house dust mite [Dermatophagoides farinae and Dermatophagoides pteronyssinus] allergen) to include the treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, in pediatric individuals aged 5 to 11 years. Source: FDA website

The Food and Drug Administration (FDA) approved Soliris® (eculizumab injection for intravenous use) for the treatment of generalized myasthenia gravis (gMG) in pediatric individuals six years of age and older who are anti-acetylcholine receptor (AChR) antibody positive. Source: FDA website

The Food and Drug Administration (FDA) approved Neffy® (epinephrine intranasal spray) for emergency treatment of type I allergic reactions, including anaphylaxis, in individuals who weigh between 15 and 30 kilograms. Source: FDA website

The Food and Drug Administration (FDA) approved Furoscix® (furosemide injection for subcutanous use) for the treatment of edema in individuals with chronic kidney disease (CKD).Source: FDA website

The Food and Drug Administration (FDA) approved Tevimbra® (tislelizumab-jsgr injection for intravenous use) in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). Source: FDA website

Central Admixture Pharmacy announced the voluntary recall of three lots of phenylephrine 40 mg added to 0.9% sodium chloride 250 mL due to visible black particular matter in a single-sealed vial. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/central-admixture-pharmacy-services-caps-issues-nationwide-recall-phenylephrine-40-mg-added-09 Source: FDA website

The Food and Drug Administration (FDA) approved Miudella® (copper intrauterine device) for the prevention of pregnancy in females of reproductive potential for up to 3 years. Source: FDA website

The Food and Drug Administration (FDA) approved CtexliTM (chenodiol tablets) for treatment of cerebrotendinous xanthomatosis (CTX) in adults. Source: FDA website

The Food and Drug Administration (FDA) approved Baqsimi (glucagon nasal powder for intranasal use) to include the treatment of severe hypoglycemia in individuals aged 1 year and older with diabetes. Source: FDA website

The Food and Drug Administration (FDA) approved Syndardy® (empagliflozin/metformin hydrochloride) and Syndardy® XR (empagliflozin/metformin hydrochloride extended-release tablets) in adults with type 2 diabetes mellitus to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression. Source: FDA website

The Food and Drug Administration (FDA) approved Iluvien® (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. Source: FDA website

The Food and Drug Administration (FDA) approved Gvoke Vialdx (glucagon injection for intravenous use) for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adults. A new 1 mg/0.2 mL single-dose vial and carton and container labeling for the intravenous use were also approved. Source: FDA website

The Food and Drug Administration (FDA) approved AmvuttraTM (vutrisiran injection for subcutaneous use) for cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits. Source: FDA website

The Food and Drug Administration (FDA) approved Tremfya® (guselkumab injection for subcutaneous or intravenous use) to treat adults with moderately-to-severely active Crohn's disease (CD), with both subcutaneous (SC) and intravenous (IV) induction options. Source: FDA website

The Food and Drug Administration (FDA) approved Fabhalta® (iptacopan capsules) for the treatment of adults with complement 3 glomerulopathy (C3G) to reduce proteinuria. Source: FDA website

The Food and Drug Administration (FDA) approved Arbli (losartan potassium oral suspension) for the treatment of hypertension in adults and children greater than 6 years old, reduction of the risk of stroke in individuals with hypertension and left ventricular hypertrophy, and treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in individuals with type 2 diabetes and a history of hypertension. Source: FDA website

The Food and Drug Administration (FDA) approved HemiclorTM (chlorthalidone tablets) for the treatment of hypertension in adults. Source: FDA website

Selected lots of IGIV and IGSC products have been withdrawn by the manufacturers due to a higher rate of allergy/hypersensitivity type reactions. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/voluntary-lot-withdrawals-immune-globulin-intravenous-igiv-and-immune-globulin-subcutaneous-igsc-0?utm_medium=email&utm_source=govdelivery Source: FDA website

Dr. Reddy’s Laboratories announced a voluntary recall of one lot of levetiracetam in 0.75% sodium chloride injection due to mislabeling of infusion bag. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-issues-nationwide-recall-levetiracetam-075-sodium-chloride-injection-1000-mg100-ml-us-due Source: FDA website

The Food and Drug Administration (FDA) approved Prezcobix® (darunavir/cobicistat tablets) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in treatment-naïve and treatment-experienced adults and pediatric individuals weighing at least 25 kg to less than 40 kg. A new fixed dose tablet containing 675 mg of darunavir and 150 mg of cobicistat is also approved. Source: FDA website

The Food and Drug Administration (FDA) approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan injection for intravenous use) to include adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy. Source: FDA website

The Food and Drug Administration (FDA) approved Imfinzi® (durvalumab injection for intravenous use) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC). Source: FDA website

The Food and Drug Administration (FDA) approved Rivfloza® (nedosiran injection for subcutaneous use) expansion to lower urinary oxalate levels in children 2 to < 9 years of age with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function. Source: FDA website

The Food and Drug Administration (FDA) approved Cabometyx® (cabozantinib tablets) for adult and pediatric individuals 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET). Source: FDA website

The Food and Drug Administration (FDA) approved Uplizna® (inebilizumab-cdon injection for intravenous use) for the treatment of immunoglobulin G4-related disease (IgG4-RD) in adults. Source: FDA website

The Food and Drug Administration (FDA) approved Vykat XRTM (diazoxide choline extended-release tablets) for the treatment of hyperphagia (chronic overeating) in adults and pediatrics 4 years of age and older with Prader-Willi syndrome (PWS). Source: FDA website

The Food and Drug Administration (FDA) approved Blujepa (gepotidacin tablets) for the treatment of female adult and pediatric individuals 12 years of age and older weighing at least 40 kg with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis. Source: FDA website

The Food and Drug Administration (FDA) approved QfitliaTM (fitusiran injection for subcutaneous use) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatrics aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors. Source: FDA website

The Food and Drug Administration (FDA) approved VanrafiaTM (atrasentan tablets) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. Source: FDA website

The Food and Drug Administration (FDA) approved Isturisa® (osilodrostat tablets) for the treatment of endogenous hypercortisolemia in adults with Cushing syndrome for whom surgery is not an option or has not been curative. Source: FDA website

The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection for subcutanous use) for the treatment of chronic spontaneous urticaria (CSU) in individuals aged 12 years and older who remain symptomatic despite H1 antihistamine treatment. Source: FDA website

The Food and Drug Administration (FDA) approved Opdivo® (nivomulab injection for intravenous use) with Yervoy® (ipilimumab injection for intravenous use) for the first-line treatment of adults with unresectable or metastatic hepatocellular carcinoma (HCC). Source: FDA website

The Food and Drug Administration (FDA) approved Opdivo® (nivomulab injection for intravenous use) with Yervoy® (ipilimumab injection for intravenous use) for adult and pediatric individuals 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). Source: FDA website

The Food and Drug Administration (FDA) approved Dextenza® (dexamethasone ophthalmic insert for intracanalicular use) for the treatment of ocular inflammation and pain following ophthalmic surgery in pediatric individuals and the treatment of ocular itching associated with allergic conjunctivitis in pediatric individuals aged 2 years and older. Source: FDA website

The Food and Drug Administration (FDA) approved Valtoco® (diazepam nasal spray) to include the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from an individual’s usual seizure pattern in individuals with epilepsy as young as 2 years old. Source: FDA website

The Food and Drug Administration (FDA) approved Vyvgart Hytrulo® (efgartigimod alfa and hyaluronidase-qvfc injection for subcutaneous use) pre-filled syringe formulation for self-administration in the treatment of adults with generalized myasthenia gravis (MG) who are anti-acetylcholine receptor antibody positive and for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). Source: FDA website

The Food and Drug Administration (FDA) approved Livmarli® (maralixibat tablets and oral solution) tablet formulation for the treatment of cholestatic pruritus in individuals 3 months of age and older with Alagille syndrome (ALGS), and for the treatment of cholestatic pruritus in individuals 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC). Source: FDA website

Amneal Pharmaceuticals announced a voluntary recall of two lots of ropivacaine hydrochloride injection 500 mg/100 mL infusion bags due to the potential presence of particulate matter. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-ropivacaine-hydrochloride-injection-usp Source: FDA website

The Food and Drug Administration (FDA) approved Rinvoq® (upadacitinib extended-release tablets) for the treatment of giant cell arteritis in adults. Source: FDA website

The Food and Drug Administration (FDA) approved Eliquis® (apixaban tablets for oral use and tablets for oral suspension) and Eliquis® Sprinkle (apixaban capsules for oral suspension) for the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric individuals from birth and older after at least 5 days of initial anticoagulant treatment, and for the addition of 0.5 mg tablets for oral suspension. Source: FDA website

The Food and Drug Administration (FDA) approved MezofyTM (aripiprazole oral film) for the treatment of schizophrenia. Source: FDA website

The Food and Drug Administration (FDA) approved QamzovaTM (meloxicam injection for intravenous use) for use in adults for the management of moderate-to-severe pain alone or in combination with non-NSAID analgesics. Source: FDA website

The Food and Drug Administration (FDA) approved AtzumiTM (dihydroergotamine nasal powder) for the acute treatment of migraine with or without aura in adults. Source: FDA website

The Food and Drug Administration (FDA) approved Penpulimab-dcqx injection with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). It was also approved as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Source: FDA website

The Food and Drug Administration (FDA) approved ZevaskynTM (prademagene zamikeracel gene-modified cellular sheets) for the treatment of wounds in adult and pediatric individuals with recessive dystrophic epidermolysis bullosa (RDEB). Source: FDA website

The Food and Drug Administration (FDA) approved ImaavyTM (nipocalimab-aahu injection for intravenous use) for the treatment of generalized myasthenia gravis (gMG) in adults and pediatrics 12 years of age and older who are anti-acetylcholine receptor (AChR+) or anti-muscle-specific tyrosine kinase (MuSK+) antibody positive. Source: FDA website

The Food and Drug Administration (FDA) approved Welireg® (belzutifan tablets) for adult and pediatric individuals 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). Source: FDA website

The Food and Drug Administration (FDA) approved Zynyz® (retifanlimab-dlwr injection for intravenous use) with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). It was also approved as a single agent for adults with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. Source: FDA website

The Food and Drug Administration (FDA) approved Brekiya® (dihydroergotamine mesylate autoinjector for subcutaneous use) for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults. Source: FDA website

The Food and Drug Administration (FDA) approved AvmapkiTM (avutometinib capsules) FakzynjaTM (defactinib tablets) Co-pack for the treatment of adults with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. Source: FDA website

The Food and Drug Administration (FDA) approved EmrelisTM (telisotuzumab vedotin-tllv injection for intravenous use) for the treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression, as determined by an FDA-approved test, who have received a prior systemic therapy. Source: FDA website

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are recommending a pause in the use of Ixchiq® (Chikungunya vaccine, live, solution for intramuscular injection) in individuals 60 years of age and older while postmarketing safety reports are investigated. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-and-cdc-recommend-pause-use-ixchiq-chikungunya-vaccine-live-individuals-60-years-age-and-older Source: FDA website

The Food and Drug Administration (FDA) approved Jivi® (antihemophilic factor, recombinant, PEGylated-aucl injection for intravenous use) to include previously treated pediatric individuals aged 7 years and older with hemophilia A (congenital Factor VIII deficiency). Source: FDA website

The Food and Drug Administration (FDA) approved Sivextro® (tablets and injection for intravenous use) to include treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric individuals <12 years of age. Source: FDA website

The Food and Drug Administration (FDA) approved PosfreaTM (palonosetron hydrochloride injection for intravenous use) to include prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy, in pediatric individuals 1 month to less than 17 years of age. Source: FDA website

The Food and Drug Administration (FDA) approved Nubeqa® (darolutamide tablets) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC). Source: FDA website

The Food and Drug Administration (FDA) approved MenQuadfi® (meningococcal groups A, C, Y, W conjugate vaccine injection for intramuscular use) for the prevention of invasive meningococcal disease in children aged 6 weeks to 23 months. Source: FDA website

The Food and Drug Administration (FDA) approved Zoryve® (roflumilast topical foam) for the treatment of plaque psoriasis of the scalp and body in adult and pediatric individuals 12 years of age and older. Source: FDA website

The Food and Drug Administration (FDA) approved Fylnetra® (pegfilgrastim-pbbk injection for subcutaneous use) to increase survival in individuals acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome, H-ARS). Source: FDA website

The Food and Drug Administration (FDA) approved Releuko® (filgrastim-ayow injection for subcutaneous or intravenous use) for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis (MAHPC) and to increase survival in individuals acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome, H-ARS). Source: FDA website

The Food and Drug Administration (FDA) approved Susvimo® (ranibizumab injection for intravitreal use via ocular implant) for the treatment of individuals with diabetic retinopathy who have previously responded to at least 2 intravitreal injections of a vascular endothelial growth factor (VEGF) inhibitor medication. Source: FDA website

The Food and Drug Administration (FDA) approved Nucala (mepolizumab injection for subcutaneous use) for the add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Source: FDA website

The Food and Drug Administration (FDA) approved Tryptyr (acoltremon) for the treatment of the signs and symptoms of dry eye disease (DED). Source: FDA website

The Food and Drug Administration (FDA) approved mNexspike (COVID-19 vaccine injection for intramuscular use) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Source: FDA website

The Food and Drug Administration (FDA) approved KhindiviTM (hydrocortisone oral solution) as a replacement therapy in pediatric individuals aged 5 years and older with adrenocortical insufficiency. Source: FDA website

The Food and Drug Administration (FDA) approved YutrepiaTM (treprostinil powder for oral inhalation) for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Source: FDA website

Amneal Pharmaceuticals announced a voluntary recall of three lots of sulfamethoxazole/trimethoprim 400 mg/80 mg tablets due to microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-sulfamethoxazole-trimethoprim-tablets-usp-400. Source: FDA website

The Food and Drug Administration (FDA) issued a warning to consumers and health care providers about the rare occurrence of severe itching after stopping long-term use of the oral allergy medications cetirizine or levocetirizine. A warning about this risk will be added to both prescription and over-the-counter (OTC) products. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warning-about-rare-severe-itching-after-stopping-long-term-use-oral-allergy-medicines?utm_medium=email&utm_source=govdelivery. Source: FDA website