The FDA approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic to treat moderate to severe acute pain in adults. Source: FDA Press Releases
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Source: FDA Press Releases
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:…
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:…
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Source: FDA Press Releases
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…
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Source: FDA Press Releases
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Source: FDA Press Releases
The FDA issued draft guidance that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials evaluating investigational medical products and/or that are conducted or supported…
The FDA issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or…