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Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...
Sarepta ( SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug ...
The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...
Parents of boys with Duchenne muscular dystrophy weigh in on drug innovation and medical regulation.
The U.S. Food and Drug Administration said on Monday it is recommending the removal of the hold placed on Sarepta ...
The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...
In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...
7don MSN
The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...
As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...
FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...
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News Nation on MSNParents urge FDA to restore gene therapy after distribution pauseA recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
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