FDA

For Immediate Release: February 28, 2025 Today, 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 of age to treat house dust mite induced nasal inflammation (allergic rhinitis), with or without eye inflammation...

For Immediate Release: March 07, 2025 Today, 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 encapsulated cell-based gene therapy for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel). MacTel is a...

For Immediate Release: March 04, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Monday, the FDA approved the first generics of Xarelto (rivaroxaban), 2.5 mg, tablets to reduce the risk of major cardiovascular events in adult patients with coronary artery disease (CAD) and to reduce the risk of...

For Immediate Release: January 16, 2025 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. This is the first time the agency has authorized products commonly referred to as nicotine pouches, which are small...

For Immediate Release: January 17, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA announced the release of a new prevention strategy aimed at combating the contamination of fresh and frozen berries with enteric viruses, such as Hepatitis A Virus and Norovirus. This strategy outlines...

For Immediate Release: January 30, 2025 Today, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain...