On December 20, 2024, the Food and Drug Administration granted accelerated approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) with cetuximab and […]

Action The U.S. Food and Drug Administration has approved Tryngolza (olezarsen), used with diet, to reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS). This […]

The Food and Drug Administration is advising consumers not to purchase or use WILDMAN, a product promoted and sold for sexual enhancement on various websites, including […]

On This Page Date: February 11, 2025 Time: 11:00 a.m. – 3:00 p.m. ET AGENDA Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT […]

Docket Number: FDA-2001-D-0067 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance is one in a […]

Docket Number: FDA-2013-D-0349 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance describes the conditions under […]

Introduction The Generic Drug Cluster has become an essential forum for international regulatory collaboration, bringing together agencies from around the world to share knowledge, address common […]

On December 18, 2024, the Food and Drug Administration approved remestemcel-L-rknd (Ryoncil, Mesoblast, Inc.), an allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, for steroid-refractory acute […]

Summary Company Announcement Date: December 16, 2024 FDA Publish Date: December 18, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains undeclared Metformin […]