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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

Reuters on MSN · 14m

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

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died,

Bloomberg on MSN · 2h

Sarepta Refused FDA’s Request to Halt Elevidys Shipments

Sarepta Therapeutics Inc. has refused to pause all shipments of its Elevidys treatment after three deaths were linked to the company’s gene therapies, the Food and Drug Administration said Friday.

FDA to ask Sarepta to stop shipping Duchenne gene therapy

The company had previously halted shipments to certain older patients following the deaths of two teenagers treated with the therapy, Elevidys.

JUUL, FDA

The Vaping Giant That Almost Died: JUUL's Shocking FDA Reversal

In a significant reversal and a major boost for the embattled vaping company, the U.S. Food and Drug Administration (FDA) on Thursday authorized the marketing of five JUUL Labs Inc. e-cigarette products,

The Washington Post · 1d

FDA lets Juul market vapes in the U.S. three years after trying to ban them

Federal regulators first announced a ban of Juul products in 2022, although a court order allowed them to stay on store shelves while the company filed an appeal.

FDA says Juul can sell vape devices and nicotine pods

The Food and Drug Administration on Thursday formally approved Juul to sell its vape devices and nicotine pods. Dr. Robert Jackler, a professor at Stanford Medicine who focuses on the impact of tobacco and advertising,

10hon MSN

FDA Issues Highest Risk Warning For Dubai Chocolate Recall

The Food and Drug Administration has updated their recall of a batch of Dubai chocolate spread to Class I, their highest ...

9h

GSK's Blood Cancer Drug Faces US Setback Due To FDA Panel's Eye Safety Warning

Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s ...

4hon MSN

FDA recalls frozen sprouted beans produced by Sugarland company for links to salmonella outbreak

Health officials have recalled two products produced by Chenak LLC, which has a location in Sugarland, for ties to a ...

1don MSN

Juul gets FDA’s OK to keep selling tobacco and menthol e-cigarettes

The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market, providing relief to a ...

Food Business News13h

FDA targets 52 food standards of identity for termination

The US Food and Drug Administration aims to revoke 52 standards of identity (SOI) across a swath of food categories, claiming ...

EatingWell on MSN2d

The FDA Just Approved a New Food Dye, but What Makes It Different?

The FDA just approved Gardenia (genipin) blue, a natural food dye, for certain foods and drinks. They’re also trying to ...

3don MSN

FDA approves new blue food dye derived from gardenia fruit

The U.S. Food and Drug Administration approved a new blue color additive derived from the fruit of the gardenia, a flowering ...

TAG24 on MSN1d

Food and Drug Administration may soon revise hormone replacement therapy warnings

US Food and Drug Administration Commissioner Marty Makary signaled Thursday that he is open to revising strict warning labels ...

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