News

Children's Hospital LA pauses use of Sarepta gene therapy for all patients
Children's Hospital Los Angeles, citing recent U.S. Food and Drug Administration actions, on Monday said it has paused usage of Sarepta Therapeutics' gene therapy Elevidys in all patients with ...
BioPharma Dive3h
FDA asks Sarepta to stop shipping Duchenne gene therapy
The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...
Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy
U.S. regulators recently asked Sarepta Therapeutics to voluntarily halt shipments of its Elevidys gene therapy after a ...
STAT5hOpinion
The crisis over Sarepta’s Duchenne therapy is a mess. But the lesson is clear
The crisis over Sarepta Therapeutics' Duchenne therapy offers a valuable lesson: Listening to critics, and responding with ...
Fierce Biotech8h
Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle ...
Zacks Investment Research on MSN8h
SRPT Down After Third Death in Muscular Dystrophy Gene Therapy Program
Shares of Sarepta Therapeutics SRPT nosedived 35.9% on Friday following the death of a patient dosed with one of its ...
Clinical Trials Arena8h
Sarepta refuses to pull gene therapy despite FDA order
Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the FDA.
Fierce Pharma9h
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 ...
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.
FDA taps biotech industry veteran as RFK Jr.'s top drug regulator
Tidmarsh, who has founded and served as CEO of several biotech companies, will lead a crucial FDA division that reviews 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.
Investor's Business Daily on MSN9h
Sarepta's 'Unprecedented Times' Continue As Company Rebukes The FDA
Sarepta stock took another dive Monday after the biotech company refused the FDA's request to voluntarily stop all shipments ...