The Reagan-Udall Foundation for the Food and Drug Administration (the Foundation) is an independent 501(c)(3) organization created by Congress “to advance the mission of the FDA […]

On November 20, 2024, the Food and Drug Administration granted accelerated approval to zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals, Inc.), a bispecific HER2-directed antibody, for previously treated, unresectable […]

Image By: Justin D. Green, MBA, MDiv., Assistant Commissioner, FDA Office of Criminal Investigations A few significant ways the U.S. Food and Drug Administration protects public […]

Summary Company Announcement Date: November 19, 2024 FDA Publish Date: November 20, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description The product contains undeclared […]

Summary Company Announcement Date: July 16, 2024 FDA Publish Date: July 17, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeled with the incorrect […]

On November 19, 2024, the Food and Drug Administration approved updated drug labeling for fludarabine phosphate (Fludarabine Phosphate Injection, Sandoz) under Project Renewal, an Oncology Center […]

On This Page Date: January 22, 2025 Time: 1:00 PM – 3:00 PM ET AGENDA Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT […]

For Immediate Release: November 19, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

[embedded content] Español 中文 Tagalog Tiếng Việt 한국어 Today you have several treatment options to prevent hospitalization and other serious complications of COVID-19. The U.S. Food and Drug Administration has […]