Category - New Drug Applications
U.S. Food and Drug Administration (FDA) Accepts for Priority Review Taiho Oncology’s New Drug Application for Futibatinib for Cholangiocarcinoma
Akebia Therapeutics Receives Complete Response Letter from the FDA for Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients
Reata Pharmaceuticals Completes Rolling Submission of New Drug Application for Omaveloxolone for the Treatment of Patients with Friedreich’s Ataxia
Outlook Therapeutics Submits Biologics License Application to the U.S. Food and Drug Administration for ONS-5010 as a Treatment for Wet AMD
Alnylam Announces 3-Month Extension of Review Period for New Drug Application for Vutrisiran
Amylyx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application (NDA) for AMX0035 for the Treatment of ALS
Travere Therapeutics Submits New Drug Application for Sparsentan for the Treatment of IgA Nephropathy
Fennec Pharmaceuticals Resubmits New Drug Application to U.S. Food And Drug Administration for Pedmark