FDA accepts for priority review a Jazz Pharmaceuticals supplemental NDA seeking revised labeling for Xyrem (sodium oxybate) oral solution, to include ...
Members of two FDA advisory committees vote overwhelmingly not to recommend approval of Pain Therapeutics Remoxy ER.
FDA releases the FDA-483s issued following inspections at two Galaxy Surfactant manufacturing facilities in India.
FDA permits the de novo marketing of Fresca Medicals Curve Positive Airway Pressure delivery system for treating obstructive sleep apnea.
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...