PTC Therapeutics faces pivotal FDA decisions for approvals that could potentially transform their long-term revenues. Click ...

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 ...

Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days ...

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

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

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

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

Shares of Sarepta Therapeutics surged Tuesday morning after the company said it had been informed by the Food and Drug Administration that it could resume shipping a drug it paused sales of last week.

Sarepta (SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the US Food and Drug ...

F.D.A. resignation: The Food and Drug Administration’s top vaccine and gene therapy official resigned on Tuesday after a ...

President Trump announced a trade deal with South Korea on Wednesday, putting 15 percent tariffs on South Korean goods, much ...

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