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FDA Grants Priority Review to Merck's Application for KEYTRUDA (pembrolizumab) Plus Concurrent Chemoradiotherapy as Treatment for Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer

20.09.2023 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for ...
United States European Network For Gynaecological Oncology Trial Foundation Inc Exchange Commission Merck Co Inc Statement Of Merck Co Inc

FDA Accepts for Priority Review Merck's Supplemental New Drug Application for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC)

Acceptance based on results from the Phase 3 LITESPARK-005 trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival compared to everolimus in...
United States Statement Of Merck Co Inc Exchange Commission Merck Research Laboratories Merck Co Inc Data Monitoring Committee

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Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adults with Non-Small Cell Lung Cancer at High Risk of Recurrence Following Complete Resection and Platinum-Based Chemotherapy

Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial ...
United States Gregory Lubiniecki Merck Research Laboratories European Union European Organisation For Research Merck Co Inc

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