The AJMC® Product Approvals and Launches page will cover the latest FDA product approvals, as well as product launches in the United States.
Garadacimab Shuts Down Contact Pathway to Treat HAE: Timothy Craig, DO
FDA Approves Garadacimab-gxii in Hereditary Angioedema
FDA Approves Perioperative Pembrolizumab in Resectable HNSCC
Mitomycin Intravesical Solution Gains FDA Approval for Recurrent Low-Grade NMIBC
FDA Approves Tablet Formulation of Zanubrutinib for All Indications
Taletrectinib Approved for ROS1-Positive NSCLC
FDA Approves Clesrovimab to Prevent RSV in Infants During First Season
Retifanlimab Approval Sets New Standard of Care in Advanced Anal Cancer: Sheela Rao, MBBS, MD, FRCP
5 Key FDA Approval Dates Mark a Milestone-Filled May
Darolutamide Gains FDA Approval for Metastatic Castration-Sensitive Prostate Cancer
FDA Approval of Mepolizumab Offers New Hope for Patients With Eosinophilic COPD: Gerard Criner, MD, FACP, FACCP
FDA Approves Roflumilast Topical Foam 0.3% for Plaque Psoriasis
FDA Approves Mepolizumab as First Once-Monthly Biologic for COPD With Eosinophilic Phenotype
FDA Approves Jivi for Pediatric Patients Aged 7 to 12 Years With Hemophilia A
Retifanlimab Becomes First FDA-Approved Frontline Treatment for Advanced Anal Cancer
Rozanolixizumab for gMG Approved in Japan for Self-Administration
Teliso-V Approved to Treat Advanced NSCLC With High c-Met Protein Overexpression
Pediatric Patients With Myasthenia Gravis Need More Treatment Options: Jonathan Strober, MD
FDA Approves First Treatment for KRAS-Mutated Recurrent LGSOC
FDA Approves Nipocalimab for Generalized Myasthenia Gravis
FDA Approves Prademagene Zamikeracel for Recessive Dystrophic Epidermolysis Bullosa
FDA Delivers CRL for Longer Dosage Intervals in Aflibercept for DME, Wet AMD
FDA Greenlights Dupilumab for Chronic Spontaneous Urticaria, Marking First Approval in a Decade
Nivolumab With Ipilimumab Approved by FDA for Use in Hepatocellular Carcinoma
New Hope for IgA Nephropathy With Atrasentan Approval: Richard Lafayette, MD, FACP
Newly Approved Triplet Regimen Boosts Survival in R/R LBCL: Craig Portell, MD
Insights Into Iptacopan in C3 Glomerulopathy: Carla Nester, MD, MSA, FASN
Inebilizumab FDA Approved as First Treatment for IgG4-RD
FDA Approves Atrasentan for Proteinuria Reduction in Primary IgA Nephropathy
Reproxalap Receives Complete Response Letter From FDA for Use in Dry Eye Disease