News

FDA Is Investigating If Sarepta’s Gene Therapy Should Stay on Market

US Food and Drug Administration Commissioner Marty Makary said he’s “taking a hard look” at whether a gene therapy from ...
Southwest Journal7d

Breaking: Second Patient Death Prompts FDA Investigation of Sarepta’s Elevidys Gene Therapy

Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...
BioPharma Dive3d

5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...
MIT Technology Review4h

The deadly saga of the controversial gene therapy Elevidys

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.
MPR3d

Third Death Prompts FDA Action on Sarepta’s Gene Therapy Products

The third death occurred in an adult male with limb girdle muscular dystrophy who received a Sarepta AAVrh74 gene therapy product, SRP-9004, in a phase 4 clinical trial.
BioPharma Dive3d

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 ...

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 ...
PharmExec1d

Recapping the Sarepta Saga—And Implications for Industry

A timeline of key developments surrounding Sarepta Therapeutics' Duchenne muscular dystrophy drug Elevidys, and the potential ...
BioSpace2d

Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle

Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the ...
NBC4 WCMH-TV on MSN6d

Sarepta Therapeutics lays off 500 employees amid FDA investigation, including 80 in Columbus

Sarepta Therapeutics announced it is laying off nearly 500 employees this week, including 80 at its Easton location.

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...
STAT2d

Pharmalittle: We’re reading about Sarepta conceding to the FDA, the U.S. transplant system, and more

Sarepta Therapeutics reversed course and agreed to halt all shipments of Elevidys, its gene therapy for Duchenne muscular ...