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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.

· 6h · on MSN

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

· 4h · on MSN

Sarepta Shares Crash on Report That FDA Will Ask It to Stop Shipping Key Drug

FDA Approves JUUL E-Cigs for Sale

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· 8h

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...

· 1d · on MSN

Juul gets FDA’s OK to keep selling tobacco and menthol e-cigarettes

· 8h

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

· 1d

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...

· 1d

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

· 1d

Juul will be allowed to sell e-cigarettes ending long fight over flavored tobacco on store shelves

· 1d

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.

· 1d

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

FOX 29 · 11h

Juul gets FDA approval to keep selling e-cigarettes

GSK, FDA and Cancer Drug

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· 1d · on MSN

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.

· 1d

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

· 17h · on MSN

GSK Falls After FDA Advisory Panel Fails to Back Cancer Drug

8hon 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 level, due to risk of salmonella contamination.

2hon 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 antipsychotic drug in combination with Viatris' antidepressant Zoloft for treating adults with PTSD.

10hon 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 Manufacturing Practices.

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Sarepta

Elevidys

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13hon 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.

18hon 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 the brink of bankruptcy.

MedPage Today1d

FDA Reviewers Flag Inconsistent Data for Rexulti in PTSD

The CAPS-5 total score ranks severity of 20 PTSD symptoms from 0 (not present) to 80 (most severe). Baseline values for the combination and placebo groups, respectively, were 38.4 and 38.7 points.

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.