Category - New Drug Applications
Obseva Announces U.S. FDA Acceptance of New Drug Application for Linzagolix
Gilead Submits Biologics License Application to U.S. Food and Drug Administration for Bulevirtide, an Investigational Treatment for People Living With Chronic Hepatitis Delta
Heron Therapeutics Announces Submission of HTX-019 NDA for the Prevention of Postoperative Nausea and Vomiting to FDA
Spectrum Pharmaceuticals Submits New Drug Application for Poziotinib
Secura Bio Announces Copiktra (duvelisib) Strategic Focus On T-cell Lymphoma And Voluntary U.S. Withdrawal Of The Relapsed Or Refractory Follicular Lymphoma Indication
BeyondSpring Pharmaceuticals Receives Complete Response Letter from the FDA for Plinabulin New Drug Application for Prevention of Chemotherapy-Induced Neutropenia (CIN)
Secura Bio Announces U.S. Withdrawal of Farydak (panobinostat) NDA
Fennec Pharmaceuticals Expects to Receive Complete Response Letter from the FDA for its New Drug Application for Pedmark™ to Prevent Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors