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FDA to Ask Sarepta to Halt Elevidys Shipments

FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths

The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after three deaths were linked to the company’s gene therapies, according to a person familiar with the matter.

Reuters on MSN · 1h

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

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

Barron's on MSN · 1h

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.

FDA approves JUUL vapes

Politico · 4h

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.

U.S. News & World Report · 1d

US FDA Approves Juul's E-Cigarettes, Source

The FDA in 2022 had banned Juul's four varieties of tobacco and menthol-flavored pods and the e-cigarette device after it concluded that the company failed to show that sale of these products would be appropriate for public health.

The Washington Post · 1d

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

Federal regulators first announced a ban of Juul products in 2022, although a court order allowed them to stay on store shelves while the company filed an appeal.

GSK, FDA and Cancer Drug

Reuters · 1d

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

The U.S. FDA's panel of independent advisers on Thursday recommended against GSK's blood cancer drug Blenrep, citing concerns about previously documented risks of eye-related side effects, sending the British drugmaker's U.

The Wall Street Journal on MSN · 7h

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.

Bloomberg on MSN · 13h

GSK Falls After FDA Advisory Panel Fails to Back Cancer Drug

GSK Plc shares tumbled after its blood cancer drug failed to secure the backing of a panel of US regulatory advisers, putting its approval in doubt.

5hon MSN

FDA Issues Highest Risk Warning For Dubai Chocolate Recall

The Food and Drug Administration has updated their recall of a batch of Dubai chocolate spread to Class I, their highest ...

MedPage Today15m

Remove Boxed Warning on Hormone Therapy for Menopause, FDA Panel Says

A panel selected by FDA Commissioner Marty Makary, MD, MPH, unanimously urged the agency to remove the boxed warning on ...

43mon 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 ...

9hon 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 ...

FDA Approves Juul E-Cigs for Sale, Years After Ban Attempt

FRIDAY, July 18, 2025 (HealthDay News) — After years of legal battles and health concerns, Juul Labs has the go-ahead to sell ...

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 ...

6hon MSN

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

The manufacturer announced a recall of 67,214 cases of its Power Stick roll-on deodorant due to violations of Current Good ...

23h

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 ...

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 ...

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FDA to Ask Sarepta to Halt Elevidys Shipments

FDA approves JUUL vapes

GSK, FDA and Cancer Drug

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