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The FDA is allowing Sarepta to resume shipments of Elevidys (delandistrogene moxeparvovec) to ambulatory patients with Duchenne muscular dystrophy.
Sarepta ( SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug ...
Shares of Sarepta Therapeutics surged Tuesday morning after the company said it had been informed by the Food and Drug ...
Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...
In the latest episode of STATus Report, Alex Hogan breaks down the confusing, heartbreaking saga of Sarepta and its gene ...
(Reuters) -Sarepta Therapeutics shares surged more than 30% before the bell on Tuesday, as analysts said the resumption of ...
Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy ...
The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...
Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...
The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...
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Sarepta allowed to continue US Elevidys shipments
It has been a tumultuous two weeks for Sarepta; however, the FDA reauthorising US shipments of Elevidys will be a welcome ...
Sarepta Therapeutics said it will voluntarily “and temporarily” pause all shipments of Elevidys® (delandistrogene ...