The AJMC® Product Approvals and Launches page will cover the latest FDA product approvals, as well as product launches in the United States.
FDA Approves RSV Vaccine for Pregnant Individuals to Prevent Virus in Infants
FDA Accepts Filing for Priority Review for Ivosidenib to Treat IDH1-Mutated R/R MDS
FDA Approves Elranatamab for Relapsed or Refractory Multiple Myeloma
FDA Grants Talquetamab Accelerated Approval for R/R Multiple Myeloma
FDA Approves Trifluridine/Tipiracil Plus Bevacizumab in Previously Treated Metastatic Colorectal Cancer
FDA Approves Beyfortus for Use in Infants With RSV
What We’re Reading: OTC Birth Control Pill Approval; Medicare Challenged; Redlining, Worse Heart Health Linked
FDA Grants Full Approval for Alzheimer Drug Lecanemab
Assessing the Impact of the Orphan Drug Act 40 Years Later
BioMarin Receives Approval for First Gene Therapy for Adults With Severe Hemophilia A
FDA Approves Rozanolixizumab-noli for Generalized Myasthenia Gravis
FDA Approves Delandistrogene Moxeparvovec, First Gene Therapy to Treat Duchenne Muscular Dystrophy
FDA Approves Talazoparib Plus Enzalutamide for mCRPC With HRR Gene Mutations
FDA Approves Glofitamab-gxbm to Treat Adults With Relapsed/Refractory DLBCL
Epcoritamab Approval Expands Treatment Armamentarium for DLBCL
What We’re Reading: FDA Approves RSV Vaccine; Medicare to Cover Alzheimer Drugs; More States Extend Postpartum Coverage
FDA Approves Olaparib Combination to Treat BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
FDA Approves Sotagliflozin, a Dual SGLT1/2 Inhibitor, for Full Range of Heart Failure
Dr Christopher Cannon on Dual SGLT1/2 Inhibitors
What We’re Reading: COVID-19 Drug Approval; Thousands Lost Medicaid Coverage; Menstrual Cycles and CVD Risk
Ninth Adalimumab Biosimilar, Yuflyma, Approved in the US
Epcoritamab Approved by FDA to Treat R/R DLBCL
FDA Expands Dapagliflozin Label to Include Reducing Risk of CV Death in Heart Failure
First Respiratory Syncytial Virus Vaccine Approved by FDA
FDA Approves Polatuzumab Vedotin Plus R-CHP for Previously Untreated DLBCL
FDA Approves Enfortumab Vedotin Plus Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma
Entresto Receives Positive Opinion From CHMP for Pediatric Heart Failure
Pembrolizumab Receives Full Approval for Select Patients With MSI-H or dMMR Solid Tumors
FDA Approves Sandoz’ High-Concentration Version of Adalimumab Biosimilar, Hyrimoz
FDA Approves Retifanlimab for Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma