FDA approves a Black Boxed warning about an increased risk of blood clots and death with Pfizers tofacitinib (Xeljanz, Xeljanz XR) 10 mg twice daily d...
FDA clears a MiRus 510(k) for the Cygnus Anterior Cervical Plate System.
FDA grants Aeglea BioTherapeutics a breakthrough therapy designation for pegzilarginase, indicated for treating Arginase 1 Deficiency.
FDA clears a Resonea 510(k) for the Drowzle Sleep Apnea Pre-screening Device.
Federal Register notice: FDA sends to OMB an information collection extension for Export of Medical Devices; Foreign Letters of Approval.
FDA releases the FDA-483 with six observations issued following an inspection at the QuVa Pharma outsourcing facility.
House Energy and Commerce Committee leaders ask FDA to explain its slower than expected progress with manufacturers and providers of stem cell product...
Bristol-Myers Squibb says a Phase 3 trial of its Opdivo failed to meet the primary clinical endpoint in specified lung cancer patients.