News

FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths
The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...
MedPage Today2h
Remove Boxed Warning on Hormone Therapy for Menopause, FDA Panel Says
A panel selected by FDA Commissioner Marty Makary, MD, MPH, unanimously urged the agency to remove the boxed warning on ...
The FDA's Newest Approval Could Have A Major Impact On Your Favorite Foods
Move over, artificial food colors, the FDA just approved gardenia (genipin) blue, a plant‑derived dye to shake up drinks and ...
Sarepta shares fall 37% as FDA questions future of key gene therapy
Sarepta Therapeutics shares plunge over 37% as FDA weighs halting shipments of its key gene therapy, Elevidys, after patient ...
BioSpace4h
Sarepta Craters as FDA Considers Requesting Halt to Elevidys Shipments
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 ...
Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says
The U.S. Food and Drug Administration is planning to request Sarepta Therapeutics to voluntarily stop all shipments of its ...
Business Times5h
Sarepta Shares Plunge 38% After Third Gene Therapy Death Sparks FDA Scrutiny
Sarepta Therapeutics saw its shares plunge more than 35% Friday after a third patient death tied to its gene therapy programs ...
Sarepta falls as report suggests FDA weighing a request to stop gene therapy shipments
Shares of Sarepta Therapeutics (NASDAQ:SRPT) continued to fall on Friday as Reuters reported that the U.S. FDA plans to ...
Asianet Newsable on MSN5h
FDA Is Reportedly ‘Taking A Hard Look’ To Evaluate Whether Sarepta’s Gene Therapy Elevidys Should Remain On The Market
The growing number of fatalities is raising questions about the future of Sarepta’s therapies and the regulatory path for ...
Sarepta shares plunge 40% as future of its gene therapy appears at risk
Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy appeared at risk.