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

Separately, Sareptea said last week that it would pause the development of most of its experimental gene therapies for a different type of muscular dystrophy. The stoppage came after one of the ...

The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...

Most Americans encounter the Federal Trade Commission only if they’ve been scammed: It handles identity theft, fraud, and ...

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

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.

Salveen Richter, Goldman Sachs lead biotech analyst, joins 'Squawk Box' to discuss the troubles facing Sarepta and its ...

EMA’s CHMP issued an opinion not to recommend Elevidys™ (delandistrogene moxeparvovec) for the treatment of ambulatory individuals with Duchenne muscular dystrophy (DMD) Roche will continue its ...

Sarepta Therapeutics suffered another major setback on Friday as Europe's drug regulator decided not to recommend the ...

Two teenage boys who took the gene therapy died of acute liver failure, and a third liver failure death last month came after a 51-year-old patient took another Sarepta gene therapy to treat a ...

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.

Since Dr. Vinay Prasad’s appointment as a key political voice within FDA, the tone of U.S. biotech policy has shifted from ...