News

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 ...
InvestorsHub on MSN4d
Sarepta Shares Drop as FDA Suspends Gene Therapy Trials for Muscular Dystrophy
Shares of Sarepta Therapeutics Inc (NASDAQ:SRPT) plunged 10% after the company disclosed that the U.S. Food and Drug ...
BioSpace3d
Sarepta Concedes to FDA Request, Suspends US Shipments of Elevidys
After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...
Pharmaceutical Technology on MSN3d
Sarepta halts Elevidys shipments following FDA pressure
Sarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.
Fierce Pharma4d
Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market
As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...
KFF Health News3d
Sarepta Suspends Elevidys Shipments After Pressure From FDA, Hospitals
Sarepta's pause on its prescription gene therapy drug for Duchenne muscular dystrophy gives the company time to work with the FDA on reviews. Infusions nationwide will be canceled. Also in the news, ...
Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...
Devdiscourse4d
Sarepta Suspends Gene Therapy Shipments After Tragic Deaths
Sarepta Therapeutics has paused U.S. shipments of its gene therapy Elevidys after two teenagers with Duchenne muscular ...
Sarepta Refused FDA’s Request to Halt Elevidys Shipments
Sarepta Therapeutics Inc. has refused to pause all shipments of its Elevidys treatment after three deaths were linked to the ...
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.
pharmaphorum4d
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 Suspends Sarepta's Gene Therapy Trials After Deaths; But Company Declines ELEVIDYS Shipment Halt
The U.S. Food and Drug Administration announced that it has placed Sarepta Therapeutics' (SRPT) investigational gene therapy trials for limb-girdle muscular dystrophy on ...