Mark Your Calendar For These September PDUFA Dates

FDA activity remained brisk in August. The FDA gave its nod for a majority of drugs that came up for review, although Vanda Pharmaceuticals Inc. (NASDAQ: VNDA)'s jet lag disorder drug Hetlioz and Sarepta Therapeutics Inc (NASDAQ: SRPT)'s Duchenne muscular dystrophy drug golodirsen failed to clear the FDA hurdle.

Seven new molecular entities, or NMEs, were approved in August, taking the total number of NME approvals thus far this year to 25 compared to 35 by the same period last year.