How a phar­ma com­pa­ny bought 2 ac­cel­er­at­ed ap­provals — nev­er ran con­fir­ma­to­ry tri­als — and cashed in un­til FDA said stop

The whole premise of the FDA’s ac­cel­er­at­ed ap­proval path­way rests on the idea that clin­i­cal ben­e­fit will be es­tab­lished af­ter the ap­proval, via a con­fir­ma­to­ry …

Endpoints News

Sign up to read this article for free.

Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.