Sarepta Therapeutics Inc. shares plunged after European regulators rejected its gene therapy Elevidys, intensifying scrutiny on the drugmaker after it was pressured to halt shipments of its treatment ...

As gene therapy maker Sarepta Therapeutics tangles with FDA over its Duchenne treatment, patients and their families are ...

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view | Although many of the complete response letters uploaded by the FDA this ...

The FDA has turned down Capricor Therapeutics’ investigational cell therapy deramiocel for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy, pointing to a lack of supporting ...

The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep under wraps more easily available to investors and the public, a move with ...

The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. The attempt may have created more questions, however, with only ...

FDA's Marty Makary says release of rejection letters will help drugmakers and investors understand decisions behind denials. But there's a big caveat.

In a bid to increase transparency, the U.S. Food and Drug Administration has begun publishing the complete response letters (CRLs) it sends to biotech companies whose drug applications it denies.

Ryan Wach shared the “hard part” of his son Zane Wach’s recovery has been drug withdrawal following his a 120-foot fall from California’s Mount Whitney in June.

With the FDA recently rejecting a drug application that aims to help those living with Barth Syndrome, one Bay Area family is frustrated by the delay of approved treatments in the rare disease ...

A common drug used for inflammatory skin conditions may hold the key to treating both alcohol addiction and pain sensitivity. That’s what scientists at a leading research institute have found.