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FDA asks Sarepta to stop shipping gene therapy

pharmaphorum · 4m

Sarepta resists as FDA seeks pause on Elevidys use

Sarepta has refused to suspend all dosing of its gene therapy for Duchenne muscular dystrophy, Elevidys, defying a clinical hold request from the FDA.

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· 2d · on MSN

Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

· 1d · on MSN

Sarepta’s Risky Gamble: Gene Therapy Stays on Market Despite FDA Request

2d

Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from ...

Sarepta Therapeutics crisis is huge blow to Duchenne families, company

The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, ...

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