~ If Approved by the FDA,
PEDMARK Stands to Be the First Therapy for the Prevention of Cisplatin-Induced Hearing Loss in Children ~
Research Triangle Park, NC,
May 28
, 2021 - Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PEDMARK
TM (a unique formulation of sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to The resubmission for PEDMARKfollows receipt of final minutes from a Type A meeting with the FDA. Importantly, the Complete Response Letter (CRL) received on August 10, 2020 referred to d
/PRNewswire/ Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS™ (sotorasib) for the treatment of.
New Drug Application granted Priority Review status, with a decision anticipated on 30 November 2021 European Medicines Agency (EMA) and Swissmedic have also validated the Marketing Authorization
Fennec Pharmaceuticals Resubmits New Drug Application to U S Food and Drug Administration for PEDMARK™ streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.