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The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...
Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...
The U.S. Food and Drug Administration said on Monday it is recommending the removal of the hold placed on Sarepta ...
FDA recommends lifting the hold on Sarepta's gene therapy Elevidys for ambulatory patients after investigation; ...
Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days ...
Parents of boys with Duchenne muscular dystrophy weigh in on drug innovation and medical regulation.
Sarepta Therapeutics shares are halted in extended trading Monday after the U.S. Food and Drug Administration (FDA) ...
Sarepta ( SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug ...
In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...
The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...
The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...
Shares of Sarepta Therapeutics surged Tuesday morning after the company said it had been informed by the Food and Drug ...
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