A half step forward for heart failure as FDA guidance leaves key question unanswered

A draft FDA guidance for heart failure endpoints could spark investment and accelerate development of cardiovascular therapies. But companies still don’t have a clear sense of when and whether they’ll need to gather mortality data -- a difference-maker for whether they should enter the space.

Settling the confusion should be a top priority for the July 26 meeting FDA is holding to discuss clinical endpoints for trials in heart failure. ...