FDA clears a Beckman Coulter Diagnostics 510(k) for its new high-sensitivity troponin assay, Access hsTnI, for use on the Access 2, DxI and all Access...
FDA releases an FDA-483 with five observations from a 2017 inspection at Exela Pharma Sciences, an outsourcing facility.
Public Citizen calls on FDA to order withdrawal of Takedas Uloric from the market due to what it says is an unacceptable risk of death.
FDA grants Revive Therapeutics an orphan drug designation for cannabidiol for treating autoimmune hepatitis, a rare disease that causes inflammation t...
Federal Register notice: FDA files for OMB approval a proposed information extension for State Enforcement Notifications.
Global Blood Therapeutics say it is in discussions with FDA about accelerated approval for its voxelotor to treat sickle cell anemia based on partial ...
FDA accepts for priority review a Jazz Pharmaceuticals supplemental NDA seeking revised labeling for Xyrem (sodium oxybate) oral solution, to include ...
ProPublica explores the possibility that)user fees and industry support of doctors have led to FDA becoming more of an industry partner than a regulat...