For Immediate Release: October 11, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Docket Number: FDA-2024-D-4774 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or we) is announcing the availability […]

On This Page Date: December 10 – 12, 2024 Day1: Tue, Dec 10 11:00 AM – 3:30 PM ET Day2: Wed, Dec 11 11:00 AM – […]

FDA regulates scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs (human and animal), biological products, and medical […]

For Immediate Release: October 11, 2024 Today, the U.S. Food and Drug Administration approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of […]

On This Page Date: October 29, 2024 Time: 8:00 AM – 5:00 PM ET Location: Event Location FDA HeadquartersFDA headquarters in White Oak, MD 10903 New […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]