Sarepta Therapeutics suffered another major setback on Friday as Europe's drug regulator decided not to recommend the approval of Elevidys, following mounting regulatory scrutiny and two recent patient deaths linked to the company's gene therapy.

The FDA is set to request Sarepta Therapeutics to halt shipments of its gene therapy, Elevidys, after a third patient's death. This marks a heightened scrutiny following previous deaths linked to the therapy.

Sarepta plummets after a third death in its muscular dystrophy program for investigational gene therapies, prompts FDA action and intensifies safety scrutiny.

A Massachusetts biotechnology company is laying off 21 employees in Durham amid a broader restructuring and pressure from federal regulators.

FDA confirms two fatal cases of liver failure in DMD patients treated with Elevidys HC Wainwright reiterates Sell rating on Sarepta, with a $10 price target Tim Melvin’s system has spotted 10X ...

FDA may face scrutiny This latest incident casts a shadow over Elevidys, Sarepta’s flagship therapy, and may increase scrutiny of the U.S. Food and Drug Administration’s decision to approve ...

FDA may face scrutiny This latest incident casts a shadow over Elevidys, Sarepta’s flagship therapy, and may increase scrutiny of the U.S. Food and Drug Administration’s decision to approve ...

Biotech firm Sarepta Therapeutics said that a second patient died after receiving its gene therapy to treat Duchenne muscular dystrophy, the latest drug to draw scrutiny after winning fast ...