The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Source: FDA Press Releases

Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis Source: FDA Drug Safety Podcasts

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 announced a proposed rule to establish and require standardized testing methods to detect and identify asbestos in talc-containing cosmetic products Source: FDA Press Releases

FDA approved the first generic referencing Victoza (liraglutide injection) 18 mg/3 mL, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10…

Today, the FDA approved the first medication for the treatment of moderate to severe obstructive sleep apnea in adults with obesity, to be used in combination with a reduced-calorie diet…

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 approved Symvess, the first acellular tissue engineered vessel for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb…

FDA announced a final rule to update the definition of the nutrient content claim “healthy” marking an important step in the agency’s nutrition priorities, which are part of a broader,…

FDA approves Ryoncil, the first mesenchymal stromal cell (MSC) therapy for treatment of steroid-refractory acute graft-versus-host disease (SR-a GVHD) in pediatric patients 2 months of age and older. Source: FDA…