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News

Sarepta, Elevidys and FDA

Yahoo · 16h
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 safety concerns.
Bloomberg on MSN · 56m
Sarepta Soars After FDA Says Some Patients Can Get Elevidys
Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients who can walk be allowed to take its gene therapy Elevidys again.
Reuters on MSN · 14h
Sarepta resumes shipping of gene therapy Elevidys to patients who can walk
Sarepta Therapeutics said on Monday it will resume shipping of its gene therapy Elevidys to patients with a rare muscular disorder who can walk, after the FDA recommended the removal of a voluntary hold that was placed on the therapy.
pharmaphorum
3h
FDA gives the go-ahead to restart Elevidys shipments
In a statement, the Cambridge, Massachusetts-based company said that shipments of Elevidys (delandistrogene moxeparvovec) will restart while it continues dialogue with the FDA "on next steps in the ...
16h
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 ...

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