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Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...
Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy
Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...
Sarepta falls after gene therapy maker pauses Elevidys shipments in US
Shares of Sarepta Therapeutics fell as much as 8% on Tuesday after the company agreed to comply with the U.S. health regulator's request to pause all shipments of its gene therapy Elevidys in the ...
Managed Healthcare Executive19h
Sarepta to Pause Shipments of the Gene Therapy Elevidys
Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators ...
In a reversal, Sarepta says it will pause shipments of gene therapy linked to deaths
By Zachary Stieber Contributing Writer In a reversal, the drugmaker Sarepta Therapeutics said July 21 it is stopping all ...
Fierce Pharma18h
Sarepta, bowing to FDA pressure, pauses shipments of Duchenne gene therapy Elevidys
A brief skirmish between Sarepta Therapeutics and the FDA has ended before escalating into a full-on regulatory clash, as the company has bowed to the agency’s demand. | A brief skirmish between ...
Becker's Hospital Review15h
Sarepta reverses course, halts gene therapy shipments following FDA request
Sarepta will stop shipping its Duchenne muscular dystrophy gene therapy Elevidys following ongoing discussions with the FDA over safety labeling. The drugmaker said the pause, effective July 22, will ...
STAT18h
Pharmalittle: We’re reading about Sarepta conceding to the FDA, the U.S. transplant system, and more
Sarepta Therapeutics reversed course and agreed to halt all shipments of Elevidys, its gene therapy for Duchenne muscular ...
Precision Medicine Online16h
Sarepta to Now Voluntarily Pause Shipments of Elevidys Duchenne Gene Therapy
The FDA had made the request Friday, which Sarepta initially rebuffed, following the death of a third patient treated with one of the firm's gene therapies.