The U.S. Food and Drug Administration (FDA) is investigating the death of an eight-year-old boy who received Sarepta ...

US regulators are investigating the death of an 8-year-old boy in Brazil who received Sarepta Therapeutics Inc.’s Elevidys.

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...

The U.S. Food and Drug Administration said on Friday that it is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics ( NASDAQ: SRPT) gene therapy for Duchenne ...

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

Sarepta Therapeutics'SRPT brutal week continued Friday after European officials rejected the company's controversial gene therapy, Elevidys.The rejection, which was delivered to European partner ...

After a tough few weeks for Sarepta Therapeutics Inc., the EMA dealt another blow on July 25, announcing it will not be ...

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

Elevidys, which is also facing regulatory hurdles in the US, was developed by Sarepta Therapeutics but is sold by Roche outside of the US.

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

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

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 ...