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FDA Approves Updated Indication for Merck s KEYTRUDA® for Treatment of Certain Patients With Urothelial Carcinoma

FDA Approves Updated Indication for Merck s KEYTRUDA® for Treatment of Certain Patients With Urothelial Carcinoma
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EMA Validates Bristol Myers Squibb s Applications for Opdivo + Yervoy and Opdivo + Chemotherapy as First-Line Treatments for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Applications based on positive results from the Phase 3 CheckMate -648 trial, in which both Opdivo -based combinations demonstrated a significant survival benefit over chemotherapy alone Bristol Myers Squibb today announced that the European Medicines Agency has validated its Type II Variation Marketing Authorization Applications for both Opdivo in combination with Yervoy and Opdivo in combination with .

FDA Approves KEYTRUDA® Plus LENVIMA® Combination for First-Line Treatment of Adult Patients With Advanced Renal Cell Carcinoma

KEYTRUDA Plus LENVIMA Is Now Approved for Two Types of Cancer, Including Advanced RCC Based on Phase 3 CLEARKEYNOTE-581 Trial, KEYTRUDA Plus LENVIMA Significantly Reduced Risk of Disease Progression or Death by 61% Versus Sunitinib Merck known as MSD outside the United States and Canada, and Eisai today announced that the U.S. Food and Drug Administration has approved the combination of KEYTRUDA, Merck’s anti-PD-1 .

FDA Grants Priority Review to Merck s Supplemental Biologics License Application for KEYTRUDA® as Adjuvant Therapy in Certain Patients With Renal Cell Carcinoma Following Surgery

FDA Grants Priority Review to Merck s Supplemental Biologics License Application for KEYTRUDA® as Adjuvant Therapy in Certain Patients With Renal Cell Carcinoma Following Surgery
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