FDA Approvals
Wegovy Approved to Treat MASH With Moderate to Advanced Fibrosis
The FDA has approved semaglutide in conjunction with diet and exercise for the treatment of MASH with moderate to ...
AUGUST 20, 2025
FDA Approves Zynyz for Squamous Cell Carcinoma of the Anal Canal
The FDA approved Zynyz with carboplatin and paclitaxel for the first-line treatment of adults with inoperable ...
MAY 21, 2025
Vanrafia Receives Accelerated Approval
The FDA granted accelerated approval to Vanrafia for proteinuria reduction in primary immunoglobulin A nephropathy.
APRIL 24, 2025
First Treatment for Cerebrotendinous Xanthomatosis Approved
The FDA approved Ctexli for the lipid storage disease cerebrotendinous xanthomatosis in adults.
FEBRUARY 24, 2025
FDA Approves Aqneursa for Neurologic Symptoms of Niemann-Pick Disease Type C
The FDA approved Aqneursa for treating neurologic symptoms of Niemann-Pick disease type C in adults and pediatric ...
SEPTEMBER 26, 2024
FDA Approves Guselkumab for UC
The FDA has approved guselkumab (Tremfya, Janssen) for patients with moderately to severely active ulcerative ...
SEPTEMBER 12, 2024
FDA Approves Seladelpar for Primary Biliary Cholangitis
The FDA has granted accelerated approval to Livdelzi in combination with ursodeoxycholic acid for adults with PBC.
AUGUST 23, 2024
FDA Approves Risankizumab for Ulcerative Colitis
The FDA has approved risankizumab (Skyrizi, AbbVie) for patients with moderate to severe ulcerative colitis.
JUNE 27, 2024
FDA Approves Interchangeable Biosimilars to Eylea
The FDA approved Yesafili and Opuviz as interchangeable biosimilars to Eylea to treat macular degeneration and ...
MAY 23, 2024
FDA Grants New Indication Subcutaneous Administration of Entyvio
The FDA approved a new indication for the subcutaneous administration of Entyvio for maintenance therapy in ...
APRIL 22, 2024
FDA Approves Maralixibat for Cholestatic Pruritus in PFIC
The FDA approved Livmarli for cholestatic pruritus in patients 5+ years with PFIC.
MARCH 17, 2024
FDA Approves Resmetirom, First Drug for MASH
The FDA granted accelerated approval to the first medication for the treatment of MASH, Rezdiffra.
MARCH 16, 2024