FDA warns Mumbai, India-based Kilitch Healthcare India about CGMP violations in its production of sterile ophthalmic drug products.
FDA warns Jiangsu, China-based Jiangsu Meifan Biotechnology Co. about CGMP violations in the production of finished OTC drugs found in an agency revie...
FDA grants Phanes Therapeutics a fast track designation for PT217 and its use in treating patients with extensive-stage small cell lung cancer with di...
Harvard Medical School researchers say fewer than half of the cancer drugs given accelerated approval between 2013 and 2023 demonstrated a clinical be...
Federal Register notice: FDA makes available its annual compilation of update notices to the agencys Susceptibility Test Interpretive Criteria Web pag...
FDA issues a written agreement with BrainStorm Cell Therapeutics under a Special Protocol Assessment on the design of the companys planned Phase 3b tr...
FDA warns Australias Antaria Pty. Ltd. about CGMP deviations in its production of active pharmaceutical ingredients.
A Congressional Research Service paper points to possible legislation Congress may want to consider to clarify how FDA is to use confidential informat...
