Shares of Sarepta Therapeutics Inc. (NASDAQ:SRPT) plunged 13% on Friday after a major regulatory blow in Europe. The European ...

On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just ...

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 ...

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

Sarepta Therapeutics Inc. (NASDAQ:SRPT) stock declined 13% Friday after European regulators recommended against approving Elevidys, the company’s gene therapy for Duchenne muscular dystrophy.

Despite all the buzz around Sarepta and concerns about Elevidys, industry watchers aren’t convinced this current controversy ...

The European drug authority recommends refusal of marketing authorization after study shows no benefit over placebo.

European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...

Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...

FDA evaluating further regulatory actions after deaths Elevidys is the only gene therapy for Duchenne muscular dystrophy Sarepta suggested updating Elevidys' label June 24 (Reuters) - The U.S ...

Sarepta has issued a safety update regarding Elevidys (delandistrogene moxeparvovec-rokl) following a second reported case of acute liver failure resulting in death. Elevidys is an adeno ...

Sarepta Therapeutics (NASDAQ: SRPT) fell ~38% in the premarket on Monday after the company reported a second fatality from acute liver failure in a patient treated with Elevidys, a gene therapy ...