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 […]

On This Page Date: September 13, 2024 Time: 8:30 AM – 5:00 PM ET What is an advisory committee? Advisory committees provide independent expert advice to […]

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 […]

On October 10, 2024, the Food and Drug Administration approved inavolisib (Itovebi, Genentech, Inc.) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, […]

As part of the reauthorizations of the Prescription Drug User Fee Act (PDUFA VI) and the Biosimilar User Fee Act (BsUFA II), the Food and Drug […]

Spanish Version [9/5/2024] FDA is warning consumers not to purchase or use Umary and Amazy products, marketed as dietary supplements, as they may be harmful to your […]

English Version [09/05/2024] La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) advierte a los consumidores de que no […]