Federal Register notice: FDA makes available a draft guidance entitled Developing Drugs for Optical Imaging.
Federal Register notice: FDA makes available a draft guidance entitled Obesity and Overweight: Developing Drugs and Biological Products for Weight Red...
FDA publishes one draft general and five specific immediately effective guidances to help establishments understand regulations governing donor eligib...
FDA grants a priority review for a Verastem Oncology NDA for avutometinib, an oral RAF/MEK clamp for use in combination with defactinib for treating c...
FDA says voluntary submission of clinical study diversity action plans increased from FY 2023 to FY 2024.
FDA warns Austin, TX-based XO Biologix that it is marketing an unapproved adulterated and misbranded product derived from amniotic fluid.
FDA grants fast-track designation to posdinemab, an investigational J&J Alzheimers drug.
A CDER drug approval reports shows that first-cycle NDA approvals fell in 2024 to 74% (37 of the 50 novel drugs approved) from 84% (46 of the 55 novel...
