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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 ...
Sarepta will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the US Food and Drug Administration ...
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 ...
Sarepta Therapeutics shares are halted in extended trading Monday after the U.S. Food and Drug Administration (FDA) ...
Parents of boys with Duchenne muscular dystrophy weigh in on drug innovation and medical regulation.
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 ...
Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe ...
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