News

Cambridge pharma company lays off almost 500 amid FDA dispute over treatment
A Cambridge-based company developing gene therapies for rare diseases is laying off more than a third of its workforce.
Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys
FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due ...
Sarepta Stock Keeps Sliding as Company Rejects FDA Call to Withdraw Drug
Sarepta Therapeutics has rejected a call by the Food and Drug Administration to stop shipments of its muscular dystrophy drug ...
pharmaphorum5h
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 ...
FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths
The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...
Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says
The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...
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 ...
BioSpace2h
Sarepta Stands Ground Against HHS Request to Stop Elevidys Shipments
In light of recent patient deaths, the FDA has also revoked its platform designation for Sarepta’s AAVrh74 technology. The ...
STAT2d
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, ...