Archive for December 2024

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 years and older with type 2 diabetes as an adjunct to diet and exercise. Source: FDA Press Releases

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 and increased physical activity. 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

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 loss, and autologous vein graft is not feasible. Source: FDA Press Releases

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, whole-of-government approach to help address an ever-growing epidemic of preventable diet-related chronic diseases. Source: FDA Press Releases

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 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 FDA approved a new treatment to be used together with glucocorticoids (steroids) to control androgen (a testosterone-like hormone) levels in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia. Source: FDA Press Releases