Abbott recalls (Class 1) its HeartMate 3 LVAS after reviewing complaints that identified blood or air leakages.
FDA issues a complete response letter for a Dynavax sBLA for a new indication for its Heplisav-B hepatitis vaccine.
FDA clears an Indica Labs 510(k) for HALO AP Dx, a digital pathology platform that the company says enables slides to be reviewed from any location as...
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for made during January, February, and March.
FDA says CTK Biotechs ImmuView Covid-19 Antigen Home Test now has a longer shelf life than previously authorized.
FDA extends by three months its review of an Ascendis Pharma NDA for TransCon PTH (palopegteriparatide) due to the companys submission of additional i...
FDA warns Uruguays Grupo Quimico SRL about CGMP violations in its work as a contract testing laboratory for drug companies.
Federal Register notice: FDA announces that it issued Day One Biopharmaceuticals a priority review voucher for its recently approved pediatric disease...
