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911 articles found
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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... -
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...
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FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic ProductsThe U.S. Food and Drug Administration today announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate th...
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HHS, CBP Seize $86.5 Million Worth of Illegal E-Cigarettes in Largest-Ever OperationThe U.S. Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA), and U.S. Customs and Border Protection (CBP) today announced the seizure of 4.7 million uni...
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FDA Issues New Guidance to Expand Non-Opioid Options for Chronic Pain, Curb MisuseDespite recent declines, opioids remain commonly prescribed to about 1 in 5 U.S. adults who live with chronic pain as effective alternatives are limited. As part of its broader strategy to address the...
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FDA Launches Green List to Protect Americans from Illegal Imported GLP-1 Drug IngredientsThe U.S. Food and Drug Administration today established a “green list” import alert to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unv...
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FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89The U.S. Food and Drug Administration today announced that it will release future complete response letters (CRLs) promptly after they are issued to sponsors. The agency also released today 89 previou...
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FDA Advances Rare Disease Drug Development with New Evidence PrinciplesThe U.S. Food and Drug Administration today introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare disease...