FDA to review Theravance’s complete response for skin infection drug
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of July 21, 2008. The FDA has indicated that it does not expect to take
HAYA Therapeutics has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational therapy, HTX-001, to treat symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).