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FDA asks Sarepta to stop shipping gene therapy

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 all shipments of its gene therapy following the death of a third patient receiving one of its treatments for muscular dystrophy.

· 20h · on MSN

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

Devdiscourse · 8h

Sarepta Defies FDA Order Amidst Gene Therapy Controversies

· 1d

FDA to ask Sarepta to stop shipping Duchenne gene therapy

The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPh...

· 1d

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

· 1d

Sarepta shares slump after third patient death this year

· 1d

Sarepta shares slump on reports of third patient death this year

On Wednesday, Sarepta announced a restructuring plan that included 500 job cuts and halting development of several gene therapies for limb-girdle muscular dystrophy.

STAT · 22h

Sarepta Therapeutics crisis is huge blow to Duchenne families, company

· 1d

Sarepta plunges after third patient death tied to gene therapy - report

23hon MSN

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.

11don MSN

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.

2don MSN

Sarepta to cut 500 jobs, add black-box warning on gene therapy

Sarepta Therapeutics will cut 500 jobs and add a serious warning on the label of its muscle-disorder gene therapy Elevidys, the drugmaker said on Wednesday, following the recent deaths of two patients who were on the medicine.

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.

1don MSN

Sarepta shares plunge 40% as future of its gene therapy appears at risk

Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy appeared at risk. Sarepta has reported three patient deaths related to its gene therapies.

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Duchenne muscular dystrophy

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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]

Fierce Healthcare4d

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.