For Immediate Release: March 20, 2025 Today, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration unveiled the Chemical Contaminants Transparency Tool (CCT Tool), an online searchable database providing a consolidated list of contaminant levels (e.g., tolerances, action levels,...
For Immediate Release: March 21, 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 Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G) to reduce proteinuria. C3G is a rare disease that causes inflammation and damage to the kidney...
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...