food and drug administration fda

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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

Sarepta Shares Crash on Report That FDA Will Ask It to Stop Shipping Key Drug

The drop comes the day after the drugmaker said it would add a so-called black-box warning to its gene therapy Elevidys after two teenage boys receiving the treatment died earlier this year.

Bloomberg on MSN · 11h

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.

U.S. News & World Report · 17h

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,

FDA approves JUUL vapes

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.

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.

Reuters on MSN · 1d

FDA approves Juul's tobacco and menthol e-cigarettes

The U.S. Food and Drug Administration has authorized the sale of Juul Labs' e-cigarette device and refill cartridges in tobacco and menthol flavors, after years of struggle with heightened regulatory scrutiny,

15hon 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 ...

22hon MSN

GSK Shares Drop After FDA Committee Vote Leaves Cancer-Drug Comeback in Doubt

The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work ...

18h

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 ...

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 ...

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 ...

Food Business News22h

FDA targets 52 food standards of identity for termination

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

21h

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 ...

4don MSN

FDA adds new blue food dye from gardenia fruit

The U.S. Food and Drug Administration on Monday approved the use of a new blue color additive from the gardenia fruit the ...

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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