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Roche’s Ventana FOLR1 assay has been approved by the FDA as the first companion diagnostic test to identify patients eligible for treatment with ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) also recently FDA approved. Read More
PerkinElmer has gained FDA marketing authorization for its EONIS assay to simultaneously detect spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns — making it the first assay authorized by the FDA for SMA screening in newborns. Read More
Despite failing to garner U.S. approval, Australian devicemaker Artrya has nabbed regulatory approvals in both the EU and UK to market its Salix CT scan analysis software for identifying arterial plague build-up that can cause coronary artery disease. Read More