The FDA investigated the death of a boy in Brazil on Elevidys and concluded it was unrelated to the treatment.

The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...

Sarepta Therapeutics said the Food and Drug Administration informed the company it can lift a voluntary pause on shipments of Elevidys for ambulatory patients with Duchenne. The company said Monday ...

On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just ...

Therapeutics announced that the U.S. FDA notified Sarepta that it may lift its voluntary pause on shipments of ELEVIDYS for ...

The U.S. Food and Drug Administration said on Monday it is recommending the removal of the hold placed on Sarepta ...

The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...

A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.

In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...

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The Food and Drug Administration is investigating Sarepta’s gene therapy products following reports of a third death from acute liver failure.

Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe ...