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FDA asks Sarepta to stop shipping gene therapy

· 1d · on MSN

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

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapy.

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· 2d · on MSN

Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

· 1d · on MSN

Sarepta’s Risky Gamble: Gene Therapy Stays on Market Despite FDA Request

3hon MSN

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 ...

How Data Secrecy Is Stalling Progress in Cell and Gene Therapy

Amid a season of regulatory and scientific advances, experts reveal a culture of data hoarding among cell and gene therapy ...

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.

Fierce Pharma6d

Ultragenyx takes another hit as FDA snubs AAV gene therapy over manufacturing issues

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

2d

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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