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

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

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...

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

This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially ...

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...

In a statement, the Cambridge, Massachusetts-based company said that shipments of Elevidys (delandistrogene moxeparvovec) will restart while it continues dialogue with the FDA "on next steps in the ...

Sarepta Therapeutics shares jumped over 36% in premarket trading on Tuesday after the company said it had received US Food ...

A 51-year-old man died last month after receiving an experimental treatment from Sarepta, the third death this year tied to ...

Sarepta Therapeutics (NASDAQ:SRPT) shares dropped sharply premarket on Monday before paring losses as Barclays revised its ...

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