Category - New Drug Applications
Italfarmaco Group Completes FDA Submission of New Drug Application for Givinostat in Duchenne Muscular Dystrophy and Receives Priority Review
Madrigal Pharmaceuticals Announces Rolling Submission of New Drug Application to U.S. FDA Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis
Astellas Announces U.S. FDA Grants Priority Review for Zolbetuximab Biologics License Application
Amneal Receives U.S. FDA Complete Response Letter for IPX203
Elevar Therapeutics Announces FDA Acceptance for Filing of New Drug Application for Rivoceranib in Combination with Camrelizumab as a First-line Treatment for Unresectable Hepatocellular Carcinoma
Madrigal Pharmaceuticals Completes Submission of New Drug Application Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis
Visiox Pharma Announces FDA Acceptance of New Drug Application for Glaucoma
Biogen and Sage Therapeutics Complete Rolling Submission of New Drug Application for Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression