FDA and Bayer post their latest Essure adverse event reports.
FDA lifts a clinical hold on Regeneron and its odronextamab monotherapy trials in patients with follicular lymphoma and diffuse large B-cell lymphoma.
FDA describes the interim communications process it will use for issues it finds when reviewing records or other information requested in lieu or in a...
FDA acting commissioner Janet Woodcock tells the Food and Drug Law Institutes annual meeting that the agency is at a critical inflection point in the ...
FDA posts a revised guidance entitled Manufacturing, Supply Chain, and Drug and Biological Product Inspections During Covid-19 Public Health Emergency...
Two FDA officials update stakeholders online about agency efforts to improve its stakeholder and outside expert interactions to advance regulatory sci...
After four years at FDA, former FDA deputy commissioner for policy, legislation, and international affairs Anna Abram joins Akin Gump as a senior advi...
FDA issues a final guidance on master protocols for Covid-19 drugs and biologics.