As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...

The drop comes the day after the drugmaker said it would add a so-called black-box warning to its gene therapy Elevidys after ...

On an investor call Friday, analysts grilled the company over its apparent lack of transparency on the matter.

The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...

In after-hours trading, shares of Sarepta (SRPT) are down 9% to $10.90. Published first on TheFly – the ultimate source for real-time, ...

The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...

Sarepta Therapeutics' licensing partner Arrowhead Pharmaceuticals said on Wednesday it expects to receive near-term milestone ...

Shares of Sarepta Therapeutics plummeted Friday following a report that a third patient has died during a clinical trial for ...

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...