Docket Number: FDA-2019-D-5473 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance addresses questions that manufacturers, […]

For Immediate Release: March 12, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

For Immediate Release: July 06, 2023 Español Today, the U.S. Food and Drug Administration converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to […]

[December 8, 2025] The U.S. Food and Drug Administration today approved the first generic version of Imvexxy® (estradiol vaginal inserts). This approval will provide women additional […]

[12/8/2025] The U.S. Food and Drug Administration (FDA) has qualified the first AI drug development tool, the AI-Based Histologic Measurement of NASH (AIM-NASH), to help pathologists […]

As outlined in the GDUFA III Commitment Letter, these performance metrics must be reported each fiscal year. Original and PAS Review GDUFA FY Performance Review Time […]

Reports Mandated by FDORA The Food and Drug Omnibus Reform Act of 2022 (FDORA) requires FDA to develop several different kinds of informational documents, including public […]

On December 4, 2025, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company) for adults with relapsed or refractory […]

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 […]