FDA asks Sarepta to stop shipping gene therapy
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JUUL GETS ITS CROWN — 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.
Rich Ice Cream Co. recalled numerous lots of its products on June 27 over potential contamination with Listeria monocytogenes.
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."
The U.S. Food and Drug Administration has authorized the sale of Juul Labs' e-cigarette device and refill cartridges in tobacco and menthol flavors, after years of struggle with heightened regulatory scrutiny,
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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.
(Reuters) -The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's drug when used in combination with Viatris' Zoloft for the treatment of adults with 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.
Federal health officials will allow Juul to keep selling its electronic cigarettes. The Food and Drug Administration said Thursday that Juul's benefits as a less harmful alternative for adult smokers outweigh the risks of teen use.
Move over, artificial food colors, the FDA just approved gardenia (genipin) blue, a plant‑derived dye to shake up drinks and candies.