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Food and Drug Administration--Press Releases
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Last updated about 19 hours ago
FDA Approves First Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disease
about 19 hours ago
The FDA approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX)...
FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
8 days ago
FDA approved the first rapid-acting biosimilar insulin product, Merilog (insulin-aspart-szij), a biosimilar...
FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices
17 days ago
The FDA is alerting patients of a safety concern regarding diabetes devices...
FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain
23 days ago
The FDA approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid...
FDA Roundup: January 17, 2025
about 1 month ago
The U.S. Food and Drug Administration is providing an at-a-glance summary of...
FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review
about 1 month ago
Today, the U.S. Food and Drug Administration authorized the marketing of 20...
FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products
about 1 month ago
FDA issued a proposed rule that, if finalized, would make cigarettes and...
FDA Roundup: January 14, 2025
about 1 month ago
The U.S. Food and Drug Administration is providing an at-a-glance summary of...
FDA Proposes Requiring At-a-Glance Nutrition Information on the Front of Packaged Foods
about 1 month ago
FDA announces a proposed rule requiring food manufacturers to display a front-of-package...
FDA Roundup: January 10, 2025
about 1 month ago
The U.S. Food and Drug Administration is providing an at-a-glance summary of...
FDA Roundup: January 7, 2025
about 2 months ago
The U.S. Food and Drug Administration is providing an at-a-glance summary of...
FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials
about 2 months ago
The FDA issued draft guidance that, when finalized, will provide recommendations for...