[11-21-2025] The Food and Drug Administration is advising consumers not to purchase or use mR.7 SUPER 700000, a product promoted and sold for male sexual enhancement on […]

On November 21, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas […]

On This Page Date: February 13 – 15, 2024 Day1: Tue, Feb 13 8:30 a.m. – 03:35 p.m. ET Day2: Wed, Feb 14 8:30 a.m. – […]

The Office of Pharmaceutical Quality (OPQ) reviews correspondence from generic drug manufacturers and related industry or their representatives related to generic drug development (i.e., controlled correspondence […]

For Immediate Release: November 19, 2025 The U.S. Food and Drug Administration today announced a pilot program designed to streamline communications with sponsors following formal meetings. […]

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 drug, […]

On November 19, 2025, the Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage small cell lung cancer […]

On November 19, 2025, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally […]

On September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs. FDA posted the […]