Garadacimab, XIIa inhibitor, receives FDA and EMA Filing acceptance for hereditary angioedema Medha Baranwal22 Dec 2023 5:45 PM ISTUSA: Garadacimab, a first-in-class factor XIIa inhibitor, has received the Food and Drug Administration (FDA) and European Medicines Agency (EMA)...
GC Pharma gets CRL from USFDA for ALYGLO MD Bureau2 March 2022 4:01 PM ISTThe FDA issues a complete response letter to indicate that the review cycle for an application is complete but the application cannot be approved in...
USFDA accepts Bristol Myers Squibb's Application for Opdivo MD Bureau2 March 2022 12:10 PM ISTThe FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 13, 2022.
