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FDA asks Sarepta to stop shipping gene therapy

Axios on MSN · 6h

Drugmaker refuses FDA request to pull gene therapy

An unusual public feud between the Food and Drug Administration and a maker of gene therapies for rare diseases could test the Trump administration's willingness to pull certain approved drugs from the market over safety concerns.

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Fierce Pharma · 1h

Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market

· 2d · on MSN

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

Fierce Biotech10m

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 ...

1hon MSN

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 Therapeutics Announces Layoff of 493 Employees, Including 80 in Ohio, Amid FDA Scrutiny and Stock Decline

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

3d

RCKT Stock Up on FDA's RMAT Tag to Gene Therapy for Heart Failure

Rocket Pharmaceuticals jumps 16.8% as FDA grants RMAT status to RP-A601 on positive phase I heart disease data.

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