On January 21, 2025, the Food and Drug Administration approved treosulfan (Grafapex, medac GmbH), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic […]

On January 27, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ […]

What are “Novel” Drugs? “Novel” drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved […]

On This Page Date: October 11, 2023 Time: 8:50 a.m. – 2:50 p.m. ET Topics & Presentations Speakers 2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials – […]

Image Español “FDA approved!” Maybe you saw those words on a company’s website or in a commercial promoting a product or treatment. Some marketers may say […]

Issued by: Guidance Issuing Office Office of the Commissioner, Office of the Chief Medical Officer, Office of Clinical Policy The following is a compilation of answers […]

Docket Number: FDA-2022-D-0286 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance […]

Docket Number: FDA-2011-D-0694 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance is intended to assist […]

Docket Number: FDA-2008-D-0386 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The development safety update report (DSUR) […]