Category - New Drug Applications
Iveric Bio Announces Completion of Rolling NDA Submission to FDA for Avacincaptad Pegol for the Treatment of Geographic Atrophy
Idorsia Submits a New Drug Application to the US FDA for Aprocitentan for the Treatment of Patients with Difficult-to-Control Hypertension
Santhera and ReveraGen Announce FDA Acceptance of New Drug Application for Vamorolone in Duchenne Muscular Dystrophy
Nirsevimab US Regulatory Submission Accepted for the Prevention of RSV Lower Respiratory Tract Disease in Infants and Children up to Age 24 Months
Phathom Pharmaceuticals Provides Update on New Drug Application Review of Vonoprazan for Erosive Esophagitis
Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)
Cytokinetics Provides Regulatory Update Related to New Drug Application for Omecamtiv Mecarbil
Travere Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Sparsentan for the Treatment of IgA Nephropathy