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 Cilta-cel to Treat R/R Multiple Myeloma
FDA Approves Empagliflozin for Broader Type of Heart Failure
Xipere for Macular Edema Associated With Uveitis Launches in United States
FDA Grants Breakthrough Device Designation to Foundation Medicine’s ctDNA Tracker
FDA Approves Sutimlimab for Cold Agglutinin Disease
FDA Approves Abrocitinib for Adults With Moderate to Severe Atopic Dermatitis
What We’re Reading: Boosters Slash COVID-19 Deaths; Generic Restasis Cleared; Medicare Advantage and Health Equity
FDA Approves Faricimab to Treat Wet AMD and DME
First-in-Class Topical Treatment Clascoterone Launches in US to Treat Acne Vulgaris
Daridorexant Approved for Adults With Insomnia
CLN-081 Receives Breakthrough Therapy Designation for NSCLC
Yusimry, the Seventh Adalimumab Biosimilar, Gains FDA Approval
FDA Approves Long-Acting, Injectable Cabotegravir to Prevent HIV
Secukinumab Approved for Pediatric Patients With ERA, PsA
What We’re Reading: Free At-Home COVID-19 Tests; Aduhelm Price Cuts; First Injectable HIV Preventive
FDA Approves Tezepelumab for Severe Asthma
Voxelotor for Sickle Cell Disease Wins FDA Nod for Patients as Young as 4
FDA Approves First CGP Test as Companion Diagnostic for BRAF Inhibitor Therapies for Melanoma
What We're Reading: FDA Panel in Favor of Merck COVID-19 Pill; Aspen Pharmacare, J&J Vaccine Agreement; Newest Strategies to Cure HIV
Novel Port Delivery System With Ranibizumab Approved in Wet AMD
FDA Approves Dupilumab for Children Aged 6 to 11 With Moderate to Severe Asthma
FDA Clears Thymus Tissue Product to Treat Congenital Athymia
FDA Approves Maralixibat to Treat Rare Pediatric Liver Disease
Ruxolitinib Cream Approved for Short-term Treatment of Atopic Dermatitis
FDA Approves Ruxolitinib for Chronic GVHD
FDA Approves First Biosimilar for Lucentis
Mobocertinib Approved in EGFR Exon 20 Insertion+ NSCLC
Zanubrutinib Gains Accelerated Approval in R/R Marginal Zone Lymphoma
FDA Approves Zanubrutinib in Adults With Waldenström Macroglobulinemia
Pfizer COVID-19 Vaccine Gains Full FDA Approval