Nova Biomedical recalls its StatStrip Glucose and Glucose/Ketone Hospital Meters due to the potential risk that a software error may cause incorrect g...
FDA clears a Roche 510(k) clearance for its cobas liat sexually transmitted infection multiplex assay panels.
In an online post, three Hyman, Phelps attorneys say two new FDA guidances show how the agency plans to enforce its requirement that confirmatory tria...
Mercks ends the HYPERION trial of Winrevair early due to positive results from earlier trials so all participants can receive the drug.
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.
