The AJMC® Product Approvals and Launches page will cover the latest FDA product approvals, as well as product launches in the United States.
The FDA has approved the first over the counter (OTC) birth control pill Thursday; the US Chamber of Commerce has filed a motion for preliminary injunction on the Medicare Drug Price Negotiation program; individuals living in historically redlined areas are likely to have worse heart health.
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FDA Approves Delandistrogene Moxeparvovec, First Gene Therapy to Treat Duchenne Muscular Dystrophy
June 22nd 2023The therapy, to be marketed as Elevidys, is approved for the treatment of ambulatory pediatric patients aged 4 through 5 years with DMD who have a confirmed mutation in the DMD gene.
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FDA Approves Talazoparib Plus Enzalutamide for mCRPC With HRR Gene Mutations
June 21st 2023Talazoparib in combination with enzalutamide showed a 55% reduction in the risk of disease progression or death for patients with metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR) gene mutations in the phase 3 TALAPRO-2 trial.
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Epcoritamab Approval Expands Treatment Armamentarium for DLBCL
June 9th 2023Tycel Phillips, MD, hematologist-oncologist at City of Hope in Duarte, CA, discussed the utility of epcoritamab in diffuse large B-cell lymphoma (DLBCL) and the potential impacts the bispecific antibody's recent approval will have in the community oncology setting.
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Dr Christopher Cannon on Dual SGLT1/2 Inhibitors
May 27th 2023Christopher P. Cannon, MD, a professor of medicine at Harvard Medical School and senior physician in the Cardiovascular Division at Brigham and Women’s Hospital, spoke about the benefit seen in a study of sotagliflozin for patients with acute heart failure.
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FDA Expands Dapagliflozin Label to Include Reducing Risk of CV Death in Heart Failure
May 9th 2023Just over a year since AstraZeneca announced topline results, the FDA has approved a label expansion to include reducing cardiovascular (CV) death and heart failure–related hospitalizations for dapagliflozin (Farxiga) based on results of the phase 3 DELIVER trial.
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Pembrolizumab Receives Full Approval for Select Patients With MSI-H or dMMR Solid Tumors
March 29th 2023The FDA has granted full approval to pembrolizumab for the treatment of some patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) solid tumors that have progressed following previous treatment.
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FDA Expands Abemaciclib Indication in HR+/HER2–, Node+, High-Risk Breast Cancer
March 7th 2023The FDA approved an expanded indication for abemaciclib (Verzenio) in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)–positive, HER2-negative, node-positive, early breast cancer that is at a high risk of recurrence.
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FDA Approves Efanesoctocog Alfa for Hemophilia A
February 24th 2023Efanesoctocog alfa is the first factor VIII therapy to overcome the interaction with endogenous von Willebrand factor, which creates a ceiling of 8 to 19 hours on the half-life of current factor VIII replacement products, which in turn creates the need for more frequent dosing.
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