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Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping its gene therapy ...
Sarepta Therapeutics said it will resume shipments of its gene therapy Elevidys® (delandistrogene moxeparvovec-rokl) “imminently” to ambulant patients with Duchenne muscular dystrophy (DMD), ending a ...
The FDA investigated the death of a boy in Brazil on Elevidys and concluded it was unrelated to the treatment.
Sarepta Therapeutics said on Monday it will resume shipping of its muscular disorder gene therapy to patients who can walk, ...
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 ...
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 ...
The U.S. Food and Drug Administration said on Monday it is recommending the removal of the hold placed on Sarepta ...
In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...
Sarepta Therapeutics (SRPT) shares dropped sharply on Monday following news that the FDA is investigating a patient death potentially connected to its gene therapy, Elevidys.
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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