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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

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...

· 1h · on MSN

FDA Will Ask Sarepta to Halt Gene Therapy Shipments After Deaths

· 4h

FDA to ask Sarepta to stop shipping Duchenne gene therapy

FDA, JUUL

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· 2h

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 c...

· 6h

Juul gets FDA approval to keep selling e-cigarettes

· 20h · on MSN

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

· 20h

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...

· 22h

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

· 1d

Juul Gets FDA's OK to Keep Selling Tobacco and Menthol E-Cigarettes

Power Stick Deodorant recalled nationwide by FDA

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· 5h · on MSN

FDA recalls over 67,000 cases of Power Stick deodorant. See where products were sold

Consumers may want to consider finding an alternative deodorant after more than 67,000 cases of Power Stick deodorants were recalled.

· 1d

More than 67,000 cases of Power Stick deodorant recalled nationwide

· 1d

Over 67,000 cases of Power Stick deodorant recalled nationwide for manufacturing issues

GSK, FDA and Cancer Drug

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· 6h · on 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.

· 22h

GSK's blood cancer drug fails to secure US FDA advisers' support

· 11h · on MSN

GSK Falls After FDA Advisory Panel Fails to Back Cancer Drug

7hon MSN

FDA Issues Risk Warning for Ice Cream Recalled in 23 States

Rich Ice Cream Co. recalled numerous lots of its products on June 27 over potential contamination with Listeria monocytogenes.

MedTech Dive3m

Whoop’s FDA warning letter sparks debate over blood pressure as a wellness metric

Whoop pushed back on the warning letter, claiming its blood pressure feature for a wearable wristband is for “wellness” and should not be regulated as a medical device.

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United States

Sarepta

Juul

Food and Drug Administration

Elevidys

21h

FDA Plans to Revoke 52 Food Standards

The 52 food standards pertain to canned fruits and vegetables, dairy products, baked goods, macaroni products, and other foods. The FDA has reviewed its portfolio of more than 250 food Standards of Identity to "make sure they are useful, relevant, and serve consumers in the best possible way."

FDA panel reassesses hormone therapy warnings in menopause treatments

The Food and Drug Administration is reassessing some warnings given about hormone therapy treatments for menopause that have led to some women avoiding the option, even if it could help them.

Medpage Today on MSN1d

CRLs Are the Low-Hanging Fruit of FDA Transparency, Experts Say

For instance, "the backlog of FOIAs ... is enormous," he said. Califf said the FDA has far greater opportunities for improved transparency -- especially in the stages of the drug approval process that happen long before CRLs are issued.