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FDA publishes a guidance with its latest questions and answers on the implementation of regulations covering expanded access to in...[ Price : $8.95]
FDA accepts for priority review an Astellas supplemental BLA for Padcev (enfortumab vedotin-ejfv) in combination with Mercks Keytr...[ Price : $8.95]
FDA awards a fast track designation to Myosin Therapeutics and its investigational drug MT-125 for treating brain cancer.[ Price : $8.95]
Alector discontinues development of latozinemab for treating a rare genetic form of frontotemporal dementia after a Phase 3 trial ...[ Price : $8.95]
FDA warns Chinas Foshan Yiying Hygiene Products Co. about CGMP issues in its production of over-the-counter drugs.[ Price : $8.95]
FDA warns Chinas Dongguan Rainbow Tech Electronic & Plastics Co. about Quality System Regulation violations in its manufacturing o...[ Price : $8.95]
The Senate Special Committee on Aging releases a report with six recommendations for reducing the use of foreign-made drugs for se...[ Price : $8.95]
FDA commissioner Marty Makary addresses during a podcast the agencys significant shift in enforcement policy directed at pha...