Category - New Drug Applications
U.S. FDA Accepts New Drug Application and Grants Priority Review for Darolutamide
Esperion Announces U.S. FDA Acceptance of New Drug Applications (NDAs) for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet for Filing and Regulatory Review
Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for Intravenous Contepo (fosfomycin) for injection
Cosmo Pharmaceuticals Announces Submission of Remimazolam NDA to FDA
Novartis Announces FDA Filing Acceptance and Priority Review of Brolucizumab (RTH258) for Patients with Wet AMD
Zogenix Receives Refusal to File Letter from U.S. Food and Drug Administration for Fintepla New Drug Application
Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Biologics License Application to U.S. FDA
Kyowa Kirin Announces FDA Acceptance of Istradefylline (KW-6002) New Drug Application Resubmission in the US