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FDA asks Sarepta to stop shipping gene therapy

Exclusive-US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says

By Bhanvi Satija (Reuters) -The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy Elevidys, a source familiar with the matter told Reuters on Friday.

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

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

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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 all shipments of its gene therapy following the death of a third patient r...

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Sarepta Therapeutics crisis is huge blow to Duchenne families, company

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Exclusive: US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says

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Researchers used gene therapy to restore hearing in adults

Groundbreaking new research shows that it is possible to use gene therapy to restore hearing in both children and adults.

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Gene Therapy for Inherited Macular Degeneration Begins Pivotal Trial

In early research, OCU410ST, a gene therapy for Stargardt disease, demonstrated slowed lesion growth by 48% at the 12-month follow-up in evaluable treated eyes.

Chinese scientists develop low-cost cell therapy for cancer, asthma and other illnesses

A team of Chinese medical experts say they can produce anti-cancer cells directly inside the human body using gene therapy tools.

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Gene-therapy company to eliminate 21 Durham employees as part of major restructuring

Massachusetts-based Sarepta Therapeutics, facing scrutiny from regulators, is reducing its global workforce by 36% in an effort to cut annual operating costs by hundreds of millions of dollars.

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Miltenyi Biotec and THSTI FIVE partner to launch India’s first hands-on CAR-T cell and gene therapy training curriculum

Our Bureau, Mumbai Friday, July 18, 2025, 17:45 Hrs [IST]

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CMS officially names participants in Cell and Gene Therapy Access Model

The Centers for Medicare and Medicaid Services (CMS) has selected 35 participants for its new, voluntary Cell and Gene Therapy Access Model. | As expected, there will be 35 voluntary participants in the CMS' new Cell and Gene Therapy Access Model.