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 ...

As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...

A Massachusetts biotechnology company is laying off nearly 500 employees, more than a third of its total workforce, as it faces pushback from the U.S. Food and Drug Administration on one of its ...

FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

Sarepta Therapeutics announced it is laying off nearly 500 employees this week, including 80 at its Easton location. According to a mass layoff notice filed with the ...

Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...

The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...

Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger ...

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Thousands of employees across US federal health agencies received an email Monday afternoon telling them they were out of a ...