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Gene Therapy Stays on Market Despite FDA Request

MedPage Today · 12h

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 the agency was investigating the three deaths due to acute liver failure following treatment with Sarepta's AAVrh74 gene therapies.

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· 2d · on MSN

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

Axios on MSN · 20h

Drugmaker refuses FDA request to pull gene therapy

3don MSN

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 ...

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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