Action The U.S. Food and Drug Administration has approved Alhemo (concizumab-mtci) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and […]

Summary Company Announcement Date: December 20, 2024 FDA Publish Date: December 20, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Product is an unapproved […]

For Immediate Release: December 20, 2024 Today, the U.S. Food and Drug Administration approved Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnea […]

For Immediate Release: December 20, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the […]

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 […]