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The FDA investigated the death of a boy in Brazil on Elevidys and concluded it was unrelated to the treatment.
Sarepta Therapeutics said the Food and Drug Administration informed the company it can lift a voluntary pause on shipments of Elevidys for ambulatory patients with Duchenne. The company said Monday ...
The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...
On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just ...
The U.S. FDA said on Monday that it recommends lifting the voluntary hold on Sarepta Therapuetics' gene therapy, Elevidys, in ...
FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt
The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular ...
Sarepta Therapeutics said on Monday it will resume shipping of its gene therapy Elevidys to patients with a rare muscular ...
The U.S. Food and Drug Administration said on Monday it is recommending the removal of the hold placed on Sarepta ...
A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.
In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...
Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe ...
NEW YORK, July 12, 2025 /PRNewswire/ -- Why: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Sarepta Therapeutics, Inc. (NASDAQ: SRPT) between June 22, 2023 ...
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