After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...

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 ...

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...

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

Reports of troubles linked to Sarepta’s Elevidys treatment for Duchenne muscular dystrophy had been popping up on social media for months — beyond the two deaths the company had already disclosed — ...

(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 ...

Sarepta Therapeutics reversed course and agreed to halt all shipments of Elevidys, its gene therapy for Duchenne muscular ...

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 pauses U.S. Elevidys shipments to complete FDA-requested safety label updates, aiming to resume distribution in the fourth quarter.

Shares of Sarepta Therapeutics fell nearly 7% on Tuesday after the company agreed to comply with the U.S. health regulator's request to pause all shipments of its gene therapy Elevidys in the United ...

After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...

Sarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.