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.

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 ...

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

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 ...

Sarepta stock down as it halts U.S. Elevidys shipments after FDA pressure and safety concerns tied to patient deaths due to liver failure.

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 ...

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 ...

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