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256 articles found
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FDA Roundup: March 7, 2025Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Wednesday, the FDA approved Encelto (revakinagene taroretcel-lwey), an allogeneic enc... -
FDA Roundup: February 28, 2025Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Thursday, the FDA approved Odactra to include use in individuals 5 through 11 years o...
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FDA Approves First Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage DiseaseToday, the U.S. Food and Drug Administration approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug to treat CTX, a very...
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FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of DiabetesToday, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients w...
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FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes DevicesToday, the U.S. Food and Drug Administration is alerting patients of a safety concern regarding diabetes devices, such as continuous glucose monitors (CGMs), insulin pumps and automated insulin dosing...
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FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific ReviewToday, the U.S. Food and Drug Administration authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientif...
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FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco ProductsToday, the U.S. Food and Drug Administration issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the lev...
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FDA Proposes Requiring At-a-Glance Nutrition Information on the Front of Packaged FoodsImage Today, the U.S. Food...
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FDA Roundup: January 14, 2025Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA issued a Request for Information (RFI) on industry practices related to p...
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FDA Roundup: January 10, 2025Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today the FDA released a Long-Term National Strategy to Increase the Resiliency of the U...