Over a dozen PDUFA dates on FDA’s August calendar

FDA has a busy PDUFA calendar next month, with goal dates coming up for at least 13 applications, 10 of which are for new therapies. That’s double the number of PDUFA dates that were on July’s calendar, and suggests that the agency’s banner year so far for NME approvals could continue. 

This week could bring a decision on zuranolone from Biogen Inc. (NASDAQ:BIIB) and Sage Therapeutics Inc. (NASDAQ:SAGE) for major depressive disorder and postpartum depression. The therapy’s PDUFA date is Saturday. ...