FDA commissioner Marty Makary addresses during a podcast the agencys significant shift in enforcement policy directed at pharmaceutical advertis...
The Senate Special Committee on Aging releases a report with six recommendations for reducing the use of foreign-made drugs for seniors.
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 accepts for priority review an Astellas supplemental BLA for Padcev (enfortumab vedotin-ejfv) in combination with Mercks Keytruda (pembrolizumab) ...
FDA warns Chinas Foshan Yiying Hygiene Products Co. about CGMP issues in its production of over-the-counter drugs.
Alector discontinues development of latozinemab for treating a rare genetic form of frontotemporal dementia after a Phase 3 trial missed its primary e...
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...
