Category Regulatory

ENHERTU® cut recurrence or death risk by 53% vs. T-DM1 in high-risk HER2+ early breast cancer (DESTINY-Breast05)

DESTINY-Breast05 Phase III Trial Demonstrates ENHERTU® Significantly Reduces Recurrence Risk in High-Risk HER2-Positive Early Breast Cancer Positive results from the DESTINY-Breast05 Phase III trial have demonstrated that ENHERTU® (fam-trastuzumab deruxtecan-nxki) provides a highly statistically significant and clinically meaningful improvement in…

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KEYTRUDA + LENVIMA Show 5-Year Survival Benefit in Advanced Endometrial Cancer

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Shows Durable 5-Year Survival Benefit Over Chemotherapy in Advanced Endometrial Carcinoma Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced updated five-year follow-up data from the pivotal Phase…

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Scanogen Granted FDA Breakthrough Device Designation

Scanogen Granted FDA Breakthrough Device Designation for Rapid Bloodstream Infection Test

Scanogen Inc., a molecular diagnostics company at the forefront of next-generation infectious disease detection, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its rapid assay designed to identify bloodstream infection pathogens directly from…

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