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256 articles found
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FDA Warns Companies Over Illegal Marketing of Botox and Related ProductsThe U.S. Food and Drug Administration issued 18 warning letters to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, commonly called Botox. The agency is aware... -
FDA Acts to Protect Children from Unapproved Fluoride Drug ProductsThe U.S. Food and Drug Administration today announced actions to restrict the sale of unapproved ingestible fluoride prescription drug products for children. The FDA sent notices to four companies out...
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FDA Moves to Accelerate Biosimilar Development and Lower Drug CostsThe U.S. Food and Drug Administration (FDA) today announced significant action to make it faster and less costly to develop biosimilar medicines, which are lower-cost “generic” alternatives to biologi...
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FDA Issues Emergency Use Authorization for New World Screwworm Drug for DogsThe U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Credelio (lotilaner) chewable tablets, concluding that, based on the scientific evidence available, it is re...
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FDA Publishes Filing Checklists to Prevent Submission DelaysThe U.S. Food and Drug Administration today made public filing checklists used internally by Center for Drug Evaluation and Research (CDER) staff to determine if a submitted application is complete an...
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A Statement From FDA Commissioner Marty Makary, M.D., M.P.H.: Encouraging Retailers to Stop Selling Illegal VapesAs part of the FDA’s broader strategy to combat the crisis of youth vaping, we are launching an initiative to increase voluntary compliance from retailers—including vape shops, convenience stores and...
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FDA Conditionally Approves First Drug for Prevention and Treatment of New World Screwworm Infestations in CattleToday, the U.S. Food and Drug Administration conditionally approved Dectomax-CA1 (doramectin injection) injectable solution for the prevention and treatment of New World screwworm larval infestations,...
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FDA Authorizes Marketing of First Eyeglass Lenses to Slow Progression of Pediatric MyopiaToday, the U.S. Food and Drug Administration authorized marketing of the Essilor Stellest eyeglass lenses to correct myopia, commonly referred to as nearsightedness, with or without astigmatism and to...
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FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)The U.S. Food and Drug Administration today removed the Risk Evaluation and Mitigation Strategies (REMS) program for Caprelsa (vandetanib), a thyroid cancer medication manufactured by Genzyme Corporat...
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FDA Grants Accelerated Approval to First Treatment for Barth SyndromeToday, the U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg. Barth sy...