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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

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 re...

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Sarepta Says It Won't Comply With FDA Request to Stop Shipping Gene Therapy Elevidys

· 14h · on MSN

Sarepta Refused FDA’s Request to Halt Elevidys Shipments

FDA approves JUUL vapes

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· 1d · on MSN

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.

· 1d · on MSN

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

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FDA approves Juul's tobacco and menthol e-cigarettes

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F.D.A. Approves Juul Vapes After Yearslong Delay

The Food and Drug Administration authorized Juul e-cigarettes for the U.S. market on Thursday, ending a lengthy standoff with regulators and lawmakers who accused the company of spurring an epidemic o...

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Juul will be allowed to sell e-cigarettes ending long fight over flavored tobacco on store shelves

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Juul can continue selling its tobacco and menthol e-cigarettes, FDA says

19hon MSN

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.

STAT3hOpinion

A sloppy report on mifepristone is being used to undermine the FDA — and the biotech industry

More than 50 biotech leaders and investors are urging the FDA to disregard a methodologically flawed report on mifepristone.

1don 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 with the FDA.

21h

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 (NYSE:GSK) Blenrep (belantamab mafodotin-blmf) combinations. The belantamab mafodotin combinations were evaluated in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.

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 expedite the ban of Red No. 3 before the January 15, 2027, deadline. Some grocers have already pledged not to sell foods with petroleum-based synthetic food dyes.

Food Business News1d

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 categories, claiming the regulations are “obsolete and unnecessary.”

4don 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 evergreen, for use in a variety of drinks and candies.

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 danger to those with a sensitivity.

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 on Hormone Replacement Therapy.