FDA to Ask Sarepta to Halt Elevidys Shipments
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FDA Authorizes Juul’s E-Cigarettes
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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.
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 manufacturer announced a recall of 67,214 cases of its Power Stick roll-on deodorant due to violations of Current Good Manufacturing Practices.
Rich Ice Cream Co. recalled numerous lots of its products on June 27 over potential contamination with Listeria monocytogenes.
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A panel selected by FDA Commissioner Marty Makary, MD, MPH, unanimously urged the agency to remove the boxed warning on hormone treatments for menopause, arguing that the strong warning has likely discouraged countless women from using a treatment that may provide benefit.
The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work with the FDA.
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."
FDA advisers on Thursday voted against GSK's blood cancer drug Blenrep, finding that its risks outweighed its benefits at the selected dose