~ FDA Prescription Drug User Fee Act (PDUFA) Target Action Date Set for September 23, 2022 ~ ~ If Approved by the FDA, PEDMARKTM Stands to Be the First.
Kyowa Kirin Announces EU Approval for the Self-administration of CRYSVITA® ▼ (burosumab) to Treat X-Linked Hypophosphataemia (XLH) apnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from apnews.com Daily Mail and Mail on Sunday newspapers.
SelteneAutoimmunerkrankung NMOSD: Erste subkutane Therapie verfügbar | PZ – Pharmazeutische Zeitung pharmazeutische-zeitung.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmazeutische-zeitung.de Daily Mail and Mail on Sunday newspapers.
~ 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