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diagnostics

Revolutionary Medical Breakthroughs of July 2025: Life-Changing Drugs, Diagnostic Wonders & Public Health Milestones

Revolutionary Medical Breakthroughs of July 2025: Life-Changing Drugs, Diagnostic Wonders & Public Health Milestones

On July 2, 2025, the FDA granted accelerated approval to linvoseltamab (Lynozyfic), a BCMA-targeting bispecific antibody, for adults with heavily pretreated relapsed/refractory multiple myeloma, after trials showed a 70% response rate. Also on July 2, 2025, the FDA approved sunvozertinib
AI Pathology Breakthrough: Roche’s Lung Cancer Diagnostic Makes FDA History

AI Pathology Breakthrough: Roche’s Lung Cancer Diagnostic Makes FDA History

In April 2025, Roche’s Ventana TROP2 (EPR20043) RxDx test became the first AI-powered diagnostic to receive FDA Breakthrough Device Designation. The device pairs an immunohistochemistry stain for TROP2 with a digital pathology AI algorithm that runs in Roche’s Navify system
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