The AJMC® Product Approvals and Launches page will cover the latest FDA product approvals, as well as product launches in the United States.
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
FDA Approves Durvalumab Combo for Muscle-Invasive Bladder Cancer
FDA Approves Fitusiran for Reducing Bleeds in Patients With Hemophilia A/B
FDA Approves Cabozantinib for Advanced Pancreatic Neuroendocrine Tumors
How Revakinagene Taroretcel Can Benefit Patients With MacTel: Dr Charles Wykoff
Revakinagene Taroretcel Approval Addresses Unmet Need in MacTel
FDA Approves Oral Iptacopan for C3 Glomerulopathy
Second CRL for Rivoceranib/Camrelizumab for Unresectable HCC
FDA Approves Guselkumab for Adult Patients With Crohn Disease
How Mirdametinib Improves QOL for People With NF1-Associated Plexiform Neurofibromas
FDA Approves Revakinagene Taroretcel for Macular Telangiectasia Type 2
FDA Expands Furosemide Injection Label to Treat Edema in CKD
FDA Approves Denosumab Biosimilars Stoboclo and Osenvelt
First-Line Tislelizumab Plus Chemotherapy Approved in ESCC Expressing PD-L1
5 Rare Diseases That Now Have Their First FDA-Approved Treatments
Adaptive Deep Brain Stimulation Technology Receives FDA Approval for Parkinson Disease
EU Approves Self-Administered Rozanolixizumab for Myasthenia Gravis
First Insulin Aspart Biosimilar Receives FDA Approval
FDA Approves Generic Lenalidomide Capsules in Multiple Strengths
Denosumab Biosimilars Approved With Interchangeability to Address Osteoporosis, Fracture Risk
Risdiplam Tablet for Spinal Muscular Atrophy Receives FDA Approval
FDA Approves Mirdametinib for Neurofibromatosis Type 1 With Plexiform Neurofibromas