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 Belimumab Autoinjector for Children With Systemic Lupus Erythematosus
Dr Migvis Monduy Explains What Sets Agamree Apart From Other Corticosteroids for DMD
First Aflibercept Biosimilars Approved in US
Ryplazim Marks First FDA Approval for Plasminogen Deficiency: Dr Amy Shapiro
Tarlatamab Receives Accelerated Approval for Extensive-Stage SCLC
FDA Grants Accelerated Approval for Liso-Cel for R/R Follicular Lymphoma
Dr Binod Dhakal: The Importance of Patient Monitoring With Cilta-Cel Treatment
Tisotumab Vedotin Gains Full FDA Approval for Recurrent or Metastatic Cervical Cancer
FDA Approves One-Time Gene Therapy Fidanacogene Elaparvovec for Hemophilia B
What We’re Reading: FDA Approves UTI Antibiotic; Ozempic, Wegovy Price Investigation; US Births Fall
Day One Marks Milestone in Pediatric Cancer as Tovorafenib Approved in BRAF-Mutated Low-Grade Glioma
Dr Binod Dhakal Discusses Game-Changing Cilta-Cel Approval for RRMM
Nogapendekin Alfa Inbakicept With BCG Approved for Type of Bladder Cancer
Benralizumab Receives FDA Approval as Add-On Maintenance Therapy for Children With Severe Asthma
FDA Approves Cilta-Cel for Earlier Treatment of RRMM
Ide-Cel Receives Approval for Earlier Treatment for Relapsed, Refractory Multiple Myeloma
FDA Approves Iloperidone for Adults With Bipolar 1 Disorder
FDA Approves AI Stethoscope for Earlier Heart Failure Detection
Factor D Inhibitor Danicopan Approved as Add-On Therapy for PNH
FDA Approves Ravulizumab-cwvz for Rare Autoimmune Disease
FDA Approves Vadadustat for Anemia in Patients With CKD Undergoing Dialysis
FDA Approves Sotatercept, First-in-Class Treatment for Adults With PAH
FDA Approves Macitentan, Tadalafil Combination Tablet for Pulmonary Arterial Hypertension
FDA Expands Labels for Nexletol, Nexlizet to Prevent Heart Attacks and Cardiovascular Procedures
Mirvetuximab Soravtansine-gynx Granted Full FDA Approval for FRα+ Platinum-Resistant Ovarian Cancer
Givinostat Receives Full FDA Approval for Duchenne Muscular Dystrophy
FDA Approves Idorsia's Tryvio for Resistant Hypertension
Agamree Now Commercially Available to Treat Duchenne Muscular Dystrophy
FDA Grants Accelerated Approval to Ponatinib Plus Chemotherapy in First-Line Ph+ ALL
FDA Approves Arsa-Cel for Metachromatic Leukodystrophy