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FDA Authorizes Juul’s E-Cigarettes

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.

ConsumerAffairs · 11h

FDA greenlights Juul’s e-cigarettes

FDA authorizes Juul’s tobacco- and menthol-flavored e-cigarettes to stay on U.S. shelves, reversing a previous ban due to new data supporting adult smoking

The Wall Street Journal on MSN · 18h

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 the brink of bankruptcy.

FDA to Ask Sarepta to Halt Elevidys Shipments

Reuters on MSN · 6h

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 · 4h

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.

Barron's on MSN · 4h

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.

GSK, FDA and Cancer Drug

The Wall Street Journal on MSN · 1d

FDA Committee Votes Against GSK Blood Cancer Drug Blenrep

The British pharmaceutical company said combinations for its Blenrep drug were evaluated in adults with relapsed or refractory multiple myeloma who have previously received at least one line of therapy.

Reuters · 1d

FDA advisers vote against combination therapies of GSK's blood cancer drug

The U.S. Food and Drug Administration's panel of independent advisers voted on Thursday against approval of GSK's blood cancer drug Blenrep for use in combination with other treatments.

Bloomberg on MSN · 16h

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.

1hon MSN

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 ...

12hon 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 Plans to Revoke 52 Food Standards

The 52 food standards pertain to canned fruits and vegetables, dairy products, baked goods, macaroni products, and other ...

BioPharma Dive6h

Panel urges FDA to remove warnings on hormonal menopause therapy

A meeting held by the FDA Thursday spotlighted debate over black box warnings that have limited use of hormone treatment for ...

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 ...

9hon 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 ...

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FDA Authorizes Juul’s E-Cigarettes

FDA to Ask Sarepta to Halt Elevidys Shipments

GSK, FDA and Cancer Drug

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