The AJMC® Product Approvals and Launches page will cover the latest FDA product approvals, as well as product launches in the United States.
Tisotumab Vedotin Gains Full FDA Approval for Recurrent or Metastatic Cervical Cancer
April 30th 2024The FDA granted full approval for tisotumab vedotin-tftv to treat recurrent or metastatic cervical cancer that progressed after chemotherapy, offering patients improved overall survival and a manageable safety profile.
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What We’re Reading: FDA Approves UTI Antibiotic; Ozempic, Wegovy Price Investigation; US Births Fall
April 25th 2024The FDA recently approved an antibiotic for the treatment of urinary tract infections (UTIs) in women; a Senate committee recently launched an investigation into the prices of Novo Nordisk’s diabetes and weight loss drugs; US births fell last year, resuming a national slide after a previous increase during the pandemic.
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Dr Binod Dhakal Discusses Game-Changing Cilta-Cel Approval for RRMM
April 24th 2024Binod Dhakal, MD, associate professor, Medical College of Wisconsin, is lead investigator of the CARTITUDE-4 study, from which data were used by the FDA to approve ciltacabtagene autoleucel (cilta-cel) for patients with relapsed/refractory multiple myeloma (RRMM) who have received at least 1 prior line of therapy.
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FDA Approves Cilta-Cel for Earlier Treatment of RRMM
April 6th 2024Most recently, the FDA’s Oncologic Drugs Advisory Committee unanimously voted to recommend ciltacabtagene autoleucel (Carvykti; Johnson & Johnson) in patients who have received at least 1 line of treatment for relapsed/refractory multiple myeloma (RRMM).
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FDA Approves Ravulizumab-cwvz for Rare Autoimmune Disease
March 28th 2024Ravulizumab-cwvz (Ultomiris) received a label expansion by the FDA for the treatment of adult neuromyelitis optica spectrum disorder in patients with anti–aquaporin-4 antibodies after trials results showed it could prevent relapses.
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FDA Approves Vadadustat for Anemia in Patients With CKD Undergoing Dialysis
March 28th 2024The FDA approved vadadustat (Vafseo), an oral medication, to treat anemia in adult patients with chronic kidney disease (CKD) on dialysis for at least 3 months. This fills a need for a new treatment option as anemia is common in these patients and can significantly impact their quality of life.
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Mirvetuximab Soravtansine-gynx Granted Full FDA Approval for FRα+ Platinum-Resistant Ovarian Cancer
March 22nd 2024Mirvetuximab soravtansine-gynx (Elahere) received full FDA approval for the treatment of folate receptor alpha–positive (FRα+), platinum-resistant ovarian cancer (PROC) based on findings from the confirmatory phase 3 MIRASOL trial.
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Givinostat Receives Full FDA Approval for Duchenne Muscular Dystrophy
March 21st 2024The approval follows fast track, orphan drug, and rare pediatric designations and an original Prescription Drug User Fee Act date of December 21, which the FDA pushed back to March 21 to have more time to review Italfarmaco’s application.
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FDA Approves Arsa-Cel for Metachromatic Leukodystrophy
March 19th 2024The approval makes atidarsagene autotemcel (arsa-cel [Lenmeldy]; Orchard Therapeutics) the first approved treatment for metachromatic leukodystrophy, a disease caused by a mutation in the ARSA gene and marked by progressive declines in both the central and peripheral nervous systems.
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FDA Approves Tislelizumab for Advanced or Metastatic ESCC After Chemotherapy
March 15th 2024The FDA has approved tislelizumab-jsgr (Tevimbra) for single-agent use in adult patients with unresectable or metastatic esophageal squamous cell carcinoma following prior systemic chemotherapy that did not include a PD-1/PD-L1 inhibitor.
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FDA Approves Resmetirom, First Treatment for NASH With Liver Fibrosis
March 14th 2024The first medication for the treatment of nonalcoholic steatohepatitis (NASH) and liver fibrosis received accelerated approval. Previously, the only treatment available to patients was implementing lifestyle changes aimed at weight reduction.
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