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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 to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reuters on Friday.

Bloomberg on MSN · 1h

FDA Will Ask Sarepta to Halt Gene Therapy 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.

Yahoo · 5h

FDA to ask Sarepta to stop shipping Duchenne gene therapy

The company had previously halted shipments to certain older patients following the deaths of two teenagers treated with the therapy, Elevidys.

FDA approves JUUL vapes

Politico · 3h

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.

The Washington Post on MSN · 21h

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.

U.S. News & World Report · 3h

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

The U.S. Food and Drug Administration (FDA) said that it will allow Juul to market its e-cigarette device and tobacco and menthol refill cartridges. The agency said the products may help adult smokers quit traditional cigarettes.

GSK, FDA and Cancer Drug

The Wall Street Journal on MSN · 6h

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.

Reuters · 23h

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.

Bloomberg on MSN · 12h

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.

4hon 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 ...

22h

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 ...

5hon 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 ...

8hon 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 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 ...

14hon MSN

FDA Authorizes Juul’s E-Cigarettes After Ban Nearly Bankrupted Firm

The regulator authorized the company to keep its e-cigarettes on the U.S. market after a federal ban in 2022 had pushed it to ...

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 Will Ask Sarepta to Halt Gene Therapy Shipments

FDA approves JUUL vapes

GSK, FDA and Cancer Drug

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