FDA warns Chinas Dongguan Rainbow Tech Electronic & Plastics Co. about Quality System Regulation violations in its manufacturing of manual emergency v...
The Senate Special Committee on Aging releases a report with six recommendations for reducing the use of foreign-made drugs for seniors.
FDA commissioner Marty Makary addresses during a podcast the agencys significant shift in enforcement policy directed at pharmaceutical advertis...
A South Carolina newspaper reports that the latest FDA inspection at Nephron Pharmaceuticals found the company still has significant quality issues.
Moderna stops the development of its congenital cytomegalovirus vaccine after it failed to meet the primary endpoint in a large Phase 3 trial.
FDA publishes the third in a series of guidances on aspects of collecting patient experience data to be used in medical product development and regula...
FDA accepts for priority review an Astellas supplemental BLA for Padcev (enfortumab vedotin-ejfv) in combination with Mercks Keytruda (pembrolizumab) ...
FDA awards a fast track designation to Myosin Therapeutics and its investigational drug MT-125 for treating brain cancer.
