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

Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.

Roche AG’s Genentech unit disclosed outcomes of two studies testing IL-33-targeting astegolimab vs. placebo on top of standard-of-care maintenance therapy in subjects with moderate to very severe ...

Sarepta Therapeutics shares closed over 5.3% lower on Monday, hitting more than a nine-year low, and fell another 8.5% in ...

H.C. Wainwright sets a rare $0 target for Sarepta Therapeutics amid FDA scrutiny over its Duchenne muscular dystrophy gene therapy Elevidys. Read more here.

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...

The FDA requested Sarepta voluntarily stop distributing Elevidys after the death of a third patient who received one of the firm's gene therapies.

Sarepta stock took another dive Monday after the biotech company refused the FDA's request to voluntarily stop all shipments ...

Drugmaker Sarepta Therapeutics said late Friday it won't comply with a request from the Food and Drug Administration to halt ...

The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.

FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due to safety concerns.