On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as […]

For Immediate Release: March 28, 2025 Today, the U.S. Food and Drug Administration approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of […]

On March 28, 2025, the Food and Drug Administration expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) to include adults with […]

[03/28/2025] FDA has identified significant data integrity and study conduct concerns with bioequivalence studies conducted by Raptim Research Pvt. Ltd., a contract research organization (CRO) based […]

On This Page Date: May 5, 2025 Time: 8:00 a.m. – 5:00 p.m. ET What is an advisory committee? Advisory committees provide independent expert advice to […]

On This Page Location Details The Universities at Shady Grove; Building II, 9630 Gudelsky Drive, Rockville, MD Event Details The In Vitro Permeation Test (IVPT) is […]

The Biologics Price Competition and Innovation Act (BPCIA), enacted March 23, 2010, was designed to create a regulatory pathway for the approval of biosimilars. It provides […]

FDA publishes a variety of lists and reports on generic drug application activities for public awareness, including: Content current as of: 03/26/2025 Regulated Product(s)

On March 26, 2025, the Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients 12 years of age and older with […]