FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes

FDA approved the first rapid-acting biosimilar insulin product, Merilog (insulin-aspart-szij), a biosimilar to its reference product Novolog (insulin aspart), to improve glycemic control in adults and children with diabetes mellitus.…

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FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices

The FDA is alerting patients of a safety concern regarding diabetes devices that rely on a smartphone to deliver critical safety alerts. The FDA has received medical device reports in…

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FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review

Today, 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 scientific review. Source:…

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FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products

FDA issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products. Source:…

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FDA Proposes Requiring At-a-Glance Nutrition Information on the Front of Packaged Foods

FDA announces a proposed rule requiring food manufacturers to display a front-of-package (FOP) nutrition label on most packaged foods. The proposed FOP nutrition label, referred to as the Nutrition Info…

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