FDA warns Exton, PA-based ProRx about multiple violations in its production of drugs as an outsourcing facility.
An FDA safety communication warns about cybersecurity vulnerabilities in Contec and Epsimed patient monitors.
Senate Health Education Labor & Pensions Committee chair Bill Cassidy (R-LA) says he is having a difficult time believing HHS secretary-nominee Robert...
FDA approves Axsome Therapeutics Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults.
FDA clears a Roche 510(k) for its Tina-quant Lipoprotein (a) Gen.2 Molarity assay that measures lipoprotein (a) in nanomoles per liter.
FDA grants OrthoPreserve a breakthrough device designation for its Defender meniscus replacement knee implant.
FDA grants orphan drug designation to March Biosciences MB-105 to treat relapsed/refractory CD5-positive T-cell lymphoma.
Adial Pharmaceuticals reports positive results from its pharmacokinetic study of ondansetron to treat alcohol use disorder
