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FDA Does 180 on Sarepta, Freeing DMD Gene Therapy for Ambulatory Patients
The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...
Sarepta Therapeutics to Lift Pause on Shipments of Duchenne Treatment Elevidys
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 ...
Sarepta Therapeutics Stock Soars After FDA Removes Hold On Elevidys For Some Patients
Sarepta Therapeutics shares are halted in extended trading Monday after the U.S. Food and Drug Administration (FDA) ...
FDA allows Sarepta to resume some Elevidys shipments
The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...
FDA recommends lifting voluntary hold on Elevidys in ambulatory patients
The U.S. FDA said on Monday that it recommends lifting the voluntary hold on Sarepta Therapuetics' gene therapy, Elevidys, in ...
Sarepta Therapeutics gets FDA green light to resume Elevidys for DMD
The U.S. Food and Drug Administration has recommended lifting the voluntary hold on Sarepta Therapeutics (NASDAQ:SRPT)’ gene therapy Elevidys for ambulatory patients with Duchenne Muscular Dystrophy ...
STAT1h
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 ...
FDA partially lifts hold on Sarepta's Duchenne gene therapy after community outcry
The FDA has partially reversed course on its push to halt shipments of a controversial gene therapy made by Sarepta ...
US FDA recommends removal of hold on Sarepta's Elevidys in some patients
The U.S. Food and Drug Administration said on Monday it is recommending the removal of the hold placed on Sarepta ...
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New FDA Drug Chief: 'Revolving Door' or Reformer?
The founder and former CEO of several pharmaceutical companies, Tidmarsh was tapped by FDA Commissioner Marty Makary, MD, MPH ...
FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys
The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...
Parents urge FDA to restore gene therapy after distribution pause
A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.