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

Sarepta will halt all shipments of Elevidys, its drug for Duchenne muscular dystrophy patients, by Tuesday evening.

Sarepta Therapeutics said it has paused all shipments of its Elevidys treatment for Duchenne muscular dystrophy in the U.S.

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 ...

There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene 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 ...

The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...

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 ...

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy to ambulatory people but maintain a halt it implemented June 15 for ...

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

A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...

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