Information about Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation
Mifeprex (mifepristone) Information
Artificial Intelligence for Drug Development
FDA recognizes the increased use of AI throughout the drug development process and across a range of therapeutic areas. Learn…
Homeopathic Products
Homeopathy is an alternative medical practice that was developed in the late 1700s.
Oncology (Cancer)/Hematologic Malignancies Approval Notifications
FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer…
FDA approves zanubrutinib for Waldenström’s macroglobulinemia
Oncology News burst
What’s New Related to Drugs
Want to know what’s new on drugs from FDA? This page provides quick links to the latest on a variety…
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer
On January 17, 2025, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.), a Trop-2-directed antibody and…
FDA D.I.S.C.O. Burst Edition: FDA approval of Ryoncil (remestemcel-L-rknd) for steroid-refractory acute graft versus host disease in pediatric patients
Listen to a soundcast of the 12.18.2024 FDA approval of Ryoncil (remestemcel-L-rknd) for steroid-refractory acute graft versus host disease in…
Pharmaceutical Science and Clinical Pharmacology Advisory Committee Roster
This page contains the Pharmaceutical Science and Clinical Pharmacology Advisory Committee roster, which lists the current members and the current…
Generic Drug Facilities, Sites and Organization Lists
Generic Drug Facilities, Sites and Organization Lists