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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

pharmaphorum · 54m

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

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

7hon MSN

FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

Sarepta Therapeutics Announces Layoff of 493 Employees, Including 80 in Ohio, Amid FDA Scrutiny and Stock Decline

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

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