Just how many employees is Sarepta Therapeutics laying off? And why did the FDA reject Ultragenyx's rare disease drug over ...

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

Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—a market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger ...

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...

Company CEO Doug Ingram said the pause was necessary for Sarepta to maintain a "productive and positive working relationship" ...

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 ...

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.

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 ...

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 U.S. FDA publishes over 200 complete response letters to enhance transparency within the agency. Read more here.

The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters related to medicines that were later approved, in a bid to improve ...