New Drug Applications Tonix Pharmaceuticals Announces PDUFA Goal Date of August 15, 2025, for FDA Decision on U.S. Marketing Approval for TNX-102 SL for Fibromyalgia 1 month ago
New Drug Applications Lexicon Announces Receipt of Complete Response Letter for Zynquista (sotagliflozin) 1 month ago
New Drug Applications Chimerix Submits Dordaviprone New Drug Application for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma 1 month ago
New Drug Applications Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients With Hypercortisolism 1 month ago
New Drug Applications NRx Pharmaceuticals, Inc. Files Initial Section of U.S. New Drug Application to the FDA for NRX-100 (IV Ketamine) for the Treatment of Suicidal Depression 1 month ago
New Drug Applications Verastem Oncology Announces FDA Acceptance and Priority Review of New Drug Application for Avutometinib in Combination with Defactinib for the Treatment of Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer 1 month ago
New Drug Applications Capricor Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy 1 month ago
New Drug Applications U.S. FDA Granted Priority Review to Dizal’s Sunvozertinib New Drug Application 1 month ago
New Drug Applications Atara Biotherapeutics Provides Regulatory and Business Update on Ebvallo (tabelecleucel) 1 month ago