The FDA asked Sarepta to pause all U.S. shipments of the DMD gene therapy Elevidys, and the company has agreed after initially refusing.

Discover key takeaways from Danaher's Q2 2025 earnings call, including robust bioprocessing growth, raised EPS guidance, and insights into future strategies.

Sarepta will stop shipping its Duchenne muscular dystrophy gene therapy Elevidys following ongoing discussions with the FDA over safety labeling. The drugmaker said the pause, effective July 22, will ...

Dr. George Tidmarsh, a Stanford pediatrics adjunct professor and former pharmaceutical executive, is FDA Commissioner Marty Makary’s pick to be the nation’s top drug regulator.

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...

The FDA had made the request Friday, which Sarepta initially rebuffed, following the death of a third patient treated with one of the firm's gene therapies.

Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the ...

(Kime, 7/21) California Healthline: Cuts To Food Benefits Stand In The Way Of RFK Jr.’s Goals For A Healthier National Diet Belinda McLoyd has been thinking about peanut butter. McLoyd, 64, receives a ...

A brief skirmish between Sarepta Therapeutics and the FDA has ended before escalating into a full-on regulatory clash, as the company has bowed to the agency’s demand. | A brief skirmish between ...

Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators ...

Sarepta Therapeutics said on Monday it will pause all shipments of Elevidys in the United States after two teenage boys with a rare condition called Duchenne muscular dystrophy, who had received the ...

The crisis over Sarepta Therapeutics' Duchenne therapy offers a valuable lesson: Listening to critics, and responding with ...