Outlook Therapeutics completes a formal dispute resolution meeting with FDA as part of the companys push to revive its approval prospects for ONS-5010...
FDA warns the University of California at San Francisco radiopharmaceutical facility about CGMP violations in its production of finished drugs.
FDA warns Par USA/Endo USA about CGMP violations in its manufacturing of finished drugs.
FDA outlines expanded efforts to reduce animal testing in drug development after reporting significant first-year progress under its roadmap to modern...
President Trump signs an executive order aimed at accelerating the development and availability of psychedelic-based treatments for patients with seri...
FDA accepts for priority review a Pfizer and Astellas Pharma supplemental BLA for Padcev (enfortumab vedotin-ejfv) that seeks to expand its use for p...
FDA updates a guidance clarifying how patients, physicians, and drug developers can access investigational therapies outside of clinical trials, incor...
Nektar Therapeutics reports new 52-week data from its mid-stage REZOLVE-AA trial, showing continued improvement in hair regrowth among patients with s...
