FDA approves a Phathom Pharmaceuticals citizen petition that corrects an agency Orange Book listing to recognize 10 years of new chemical entity exclu...
FDA says a Draeger recall of breathing circuit components is Class 1.
FDA publishes the International Council on Harmonization technical representation of its M11 guideline protocol template.
The House Appropriations Committee posts FDAs budget bill for FY 2026 that mirrors the Trump Administrations budget proposal that would decrease the a...
FDA grants platform technology designation to a Sarepta viral vector used in an investigational gene therapy to treat a form of muscular dystrophy.
FDA posts a draft guidance entitled Hernia Mesh Package Labeling Recommendations.
FDA confirms that all drugs now have updated labeling to better provide health risk information to pregnant women.
California, Massachusetts, New Jersey, and New York ask FDA to cancel the mifepristone REMS program requirements in their states or decline to enforce...
