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FDA to Ask Sarepta to Halt Elevidys Shipments

Exclusive-US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says

By Bhanvi Satija (Reuters) -The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy Elevidys, a source familiar with the matter told Reuters on Friday.

· 3h · on MSN

FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths

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Sarepta shares plunge 30% as future of its gene therapy appears at risk

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

The U.S. Food and Drug Administration will request Sarepta Therapeutics (SRPT.O) to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reuters on Fri...

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Sarepta Therapeutics lays off one-third of workforce in drastic cost-cutting

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Sarepta Therapeutics, Inc. (SRPT) Strategic Restructure and ELEVIDYS Label Update Call Transcript

FDA, JUUL

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

The FDA determined that the evidence provided by the company, including new information the company submitted in response to a deficiency letter from the FDA, demonstrates that these specific product...

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

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FDA says Juul can sell vape devices and nicotine pods

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FDA approves Juul's tobacco and menthol e-cigarettes

Juul Labs said on Thursday the U.S. Food and Drug Administration has authorized the sale of its e-cigarette device and refill cartridges in tobacco and menthol flavors, after years of struggle with h...

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

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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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FDA reverses ban on sale of Juul e-cigarettes

“Today’s FDA authorization of JUUL products marks an important step toward making the cigarette obsolete,” K.C. Crosthwaite, Juul Labs’s CEO, said in a statement.

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

FOX 29 · 11h

Juul gets FDA approval to keep selling e-cigarettes

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US FDA advisers recommend 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 antipsychotic drug in combination with Viatris' antidepressant Zoloft for treating adults with PTSD.

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.

2hon 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 salmonella outbreak.

Food Business News11h

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 the regulations are “obsolete and unnecessary.” Under the proposal, announced July 16,

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

CSP Daily News5h

FDA, FTC warn companies for illegally selling Delta-8 products

Delta-8 is a substance found in the cannabis sativa plant, of which marijuana and hemp are two varieties, the agency said. Delta-8 THC products have not been evaluated or approved by the FDA for safe use and may be marketed in ways that put the public health at risk, the FDA said.

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.

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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 drug when used in combination with Viatris' Zoloft for the treatment of adults with PTSD.

TAG24 on MSN23h

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.