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STAT1hOpinion

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 ...
MyChesCo on MSN2h

FDA Shuts Down Sarepta Gene Therapy Trials After Three Deaths Linked to Liver Failure

The U.S. Food and Drug Administration on Friday placed Sarepta Therapeutics’ gene therapy trials for limb girdle muscular ...
MedPage Today2h

Drugmaker Refuses FDA's Request to Pull Gene Therapy Tied to Patient Deaths

The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...
BioPharma Dive2h

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

A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...
MPR3h

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.
Fierce Biotech3h

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 ...
Precision Medicine Online4h

Sarepta to Continue to Ship Duchenne Gene Therapy Elevidys Despite FDA Request

The FDA requested Sarepta voluntarily stop distributing Elevidys after the death of a third patient who received one of the firm's gene therapies.
Fierce Pharma4h

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.

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.
STAT5h

Pharmalittle: We’re reading about Sarepta resisting FDA over Elevidys, agency naming top drug regulator, and more

Sarepta Therapeutics refused a FDA request to halt shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy ...
WBUR6h

Cambridge-based gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths

Drugmaker Sarepta Therapeutics said late Friday it won't comply with a request from the Food and Drug Administration to halt ...