FDA Roundup: December 27, 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 Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
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 Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes
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…
FDA Approves First Medication for Obstructive Sleep Apnea
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…
FDA Roundup: December 20, 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 Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in Extremities
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 Updates “Healthy” Claim, Providing a Refreshed Tool for Consumers
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 First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease
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…
FDA Roundup: December 17, 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 Approves New Treatment for Congenital Adrenal Hyperplasia
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…