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

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

In the latest of a string of issues Sarepta has faced, the CHMP said it was recommending against approval as the pivotal ...

Shares of Sarepta Therapeutics fell close to 37% on Friday after reports emerged that the US Food and Drug Administration is ...

The FDA has come up with a series of ... some added regulatory context on troublesome issues like the added threat of adverse ... before green-lighting the drug. But with Sarepta, ...

Elevidys is a gene therapy approved to treat Duchenne muscular dystrophy. Last month, Sarapta halted sales of the therapy for non-ambulatory patients.

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

The FDA won’t be holding an advisory panel meeting for Sarepta Therapeutics’ SRP-9001, which is now that much closer to becoming the first gene therapy for Duchenne muscular dystrophy (DMD).

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

Sarepta Therapeutics (NASDAQ:SRPT) fell victim to the FDA's whims as the stock tumbled more than 3 percent following the issues raised by the FDA against its drug candidate Vyondys 53 ...