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

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

Vinay Prasad, M.D., has left the FDA, less than three months into the role as director of the Center for Biologics Evaluation ...

Sarepta Therapeutics Inc. announced that the company plans to temporarily pause all shipments of its gene therapy to treat ...

Sarepta Therapeutics Inc. (NASDAQ:SRPT) is one of the most undervalued stocks to buy and hold for 3 years. On July 22, BMO ...

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 ...

It has been a tumultuous two weeks for Sarepta; however, the FDA reauthorising US shipments of Elevidys will be a welcome development.

Sarepta Therapeutics now trades at book value with strong cash and cost-cutting plans, while ELEVIDYS may regain broader use.

Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...

FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due to safety concerns.

Sarepta Therapeutics said it will voluntarily “and temporarily” pause all shipments of Elevidys® (delandistrogene ...