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FDA clears an Indica Labs 510(k) for HALO AP Dx, a digital pathology platform that the company says enables slides to be reviewed ...[ Price : $8.95]
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for made during January, Fe...[ Price : $8.95]
FDA says CTK Biotechs ImmuView Covid-19 Antigen Home Test now has a longer shelf life than previously authorized.[ Price : $8.95]
FDA extends by three months its review of an Ascendis Pharma NDA for TransCon PTH (palopegteriparatide) due to the companys submis...[ Price : $8.95]
FDA warns Uruguays Grupo Quimico SRL about CGMP violations in its work as a contract testing laboratory for drug companies.[ Price : $8.95]
Federal Register notice: FDA announces that it issued Day One Biopharmaceuticals a priority review voucher for its recently approv...[ Price : $8.95]
FDA clears a Qiagen 510(k) for the QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use in diagnosing upper respirato...[ Price : $8.95]
FDA warns Azusa, CA-based Woodward Laboratories about CGMP violations in its production of finished drugs.