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...
FDA asks members of its Anesthetic and Analgesic Drug Products Advisory Committee to discuss several challenges the agency has identified in a BLA for...
Vanda Pharmaceuticals criticizes FDA for failing to approve the companys NDA for tradipitant to treat the symptoms of gastroparesis.
