Sarepta said it accepts the CHMP decision on Elevidys, while partner Roche said it will continue working with the EMA.

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

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

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 ...

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

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 ...

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, acknowledges that the ...

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

The Swiss pharmaceutical group said the negative opinion from the European Medicines Agency was based on data that included a phase 3 study in which Elevidys didn't meet its primary endpoint after one ...

European regulators said that a Duchenne gene therapy should not be approved, imperiling the treatment that is also facing ...

Friday said that the European Medicines Agency has issued a negative opinion on the conditional marketing authorization for Elevidys, intended for ambulatory patients aged three to seven with Duchenne ...

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