Sarepta Elevidys FDA Investigation - Search News

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FDA, Sarepta Therapeutics and Elevidys

The Boston Globe · 1d

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 · 5d

FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received Sarepta Therapeutics' muscular disorder gene therapy Elevidys.

The American Journal of Manage… · 1h

FDA Recommends Sarepta Resume DMD Gene Therapy Shipments for Ambulatory Patients

Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a voluntary pause.

Fierce Pharma3d

FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault

In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...

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 ...

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