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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

Reuters on MSN · 28m

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.

FDA, JUUL

UPI on MSN · 1d

FDA approves Juul e-cigarette and cartridge sales

Officials with the Food and Drug Administration have approved the continued sales of tobacco-flavored e-cigarettes and refill cartridges by Juul Labs.

CNN on MSN · 1d

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 company that has struggled for years after being widely blamed for sparking the teen vaping trend.

Politico · 10h

FDA makes Juul’s reign official

The FDA authorized Juul’s applications on Thursday to sell e-cigarettes in the U.S., determining they’re “appropriate for the protection of public health” because their benefits to adult smokers of combustible cigarettes outweigh the risks to nonsmoking youths.

6hon MSN

US FDA advisers vote against Otsuka's PTSD combination treatment

The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma'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 ...

12h

The FDA Announces Recall on Bread Sold at Walmart and Kroger in These States

Lewis Bake Shop is issuing a voluntary recall on their Artisanal Style 1/2 Loaf, which contains undisclosed hazelnuts — 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 ...

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 ...

MPR11h

FDA Plans to Revoke 52 Food Standards

HealthDay News — The US Food and Drug Administration has announced a plan to revoke 52 food standards after concluding they ...

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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