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...
A KFF Health News report carried online by NBC says 10 members of an FDA advisory committee evaluating an Abbott cardiac device had received money fro...
CDER Office of Prescription Drug Promotion researchers say disclosing methodological rigor in communications to healthcare providers may help them for...
