FDA Accepts Axsome Therapeutics NDA for AXS-07

FDA Accepts Axsome Therapeutics NDA for AXS-07

Biopharmaceutical company Axsome Therapeutics, known for developing innovative therapies for central nervous system (CNS) disorders, announced that the FDA (Food and Drug Administration) has accepted their New Drug Application (NDA) for AXS-07 for acute migraine...
Fennec Pharmaceuticals Resubmits NDA for PEDMARK™

Fennec Pharmaceuticals Resubmits NDA for PEDMARK™

Fennec Pharmaceuticals has resubmitted their New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PEDMARK™, a unique sodium thiosulfate formulation. PEDMARK is designed to prevent ototoxicity caused by cisplatin chemotherapy in patients under...
NDA Submitted by Antengene in South Korea

NDA Submitted by Antengene in South Korea

Antengene submitted yesterday (1/3) a New Drug Application (NDA) with Orphan Drug Designation (ODD) to South Korea’s regulatory body, the Ministry of Food and Drug Safety (MFDS), for ATG-010 (selinexor). The NDA is specifically for the approval of ATG-010 (selinexor)...