FDA selects seven companies from 80 applications to participate in the agencys PreCheck Pilot Program to advance U.S. drug manufacturing.
FDA publishes a guidance on submitting next-generation sequencing data to CDERs Division of Antivirals.
FDA approves Orca Biosystems Tregzi to improve chronic graft-versus-host disease (GVHD)-free survival in adults with blood cancers undergoing allogene...
FDA warns Indias Wizcure Pharmaa about CGMP violations in its production of over-the-counter drugs.
FDA warns Chinas Yangzhou Hongshengding Chemical Co. about not responding to agency requests for records on its over-the-counter drug manufacturing op...
CBER publishes a Standard Operating Policy and Procedure on implementing and maintaining REMS.
FDA approval numbers show it approved 23 novel drugs during the first six months of 2026, maintaining a pace that would be consistent with recent year...
FDA sends Ascelia Pharma a Complete Response Letter regarding its NDA for Orviglance, a contrast agent for liver imaging.
