Sarepta Therapeutics announced late Friday evening that it will not comply with the Food and Drug Administration's ...

Drugmaker Sarepta Therapeutics said it won’t comply with a request from the FDA to halt all shipments of its gene therapy ...

Sarepta Therapeutics refuses the FDA request to halt its gene therapy shipments following a third patient death, challenging ...

In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...

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

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

Sarepta Therapeutics Inc. has refused to pause all shipments of its Elevidys treatment after three deaths were linked to the ...

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

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Ele­vidys, after three patients died from ...

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 ...

The rollercoaster week for Sarepta Therapeutics continued, with shares of the embattled gene therapy-turned-siRNA biotech down 37% Friday afternoon as media outlets reported FDA plans to request a ...

The company had previously halted shipments to certain older patients following the deaths of two teenagers treated with the ...