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Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...
There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.
Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...
Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the ...
After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy to ambulatory people but maintain a halt it implemented June 15 for ...
(Kime, 7/21) California Healthline: Cuts To Food Benefits Stand In The Way Of RFK Jr.’s Goals For A Healthier National Diet Belinda McLoyd has been thinking about peanut butter. McLoyd, 64, receives a ...
Shares of Sarepta Therapeutics fell nearly 7% 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 United ...
Sarepta Therapeutics (SRPT) said late Monday it will pause all shipments of its Duchenne muscular dystrophy gene therapy, ...
Sarepta Therapeutics said on Monday that it will pause all shipments of its Elevidys gene therapy in the United States after a muscular dystrophy patient who received a different, experimental ...
The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...
A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...
Allegations in the Complaint Sarepta is a biopharmaceutical company focused on genetic medicine, including its gene therapy product ELEVIDYS, developed for the treatment of Duchenne muscular ...