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

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

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

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

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

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

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

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

Arrowhead Pharmaceuticals has moved to reassure Wall Street about its deal with Sarepta Therapeutics, telling investors that ...

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

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...

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