Approval Based News Today

This is an accelerated approval for use in patients with folate receptor alpha–positive disease, identified by an assay that was approved alongside the drug.

– Approval Based on Results from ACTIVATE and ACTIVATE-T Phase 3 Studies, Supports Treatment of Adults with PK Deficiency Regardless of Transfusion Status...

KEYTRUDA ® is an anti-PD-1 therapy that works by helping increase the ability of the bodys immune system to help detect and fight tumour cells. 1 An estimated 26,900 Canadians were diagnosed with colorectal cancer in 2020, with an average of 73 Canadians diagnosed daily. 2 KIRKLAND, QC, March 8, 2021 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that Health Canada has approved KEYTRUDA ® (pembrolizumab), Mercks anti-PD-1 therapy, for the first...

Approval Based on Significant Progression Free Survival Findings from Phase 3 KEYNOTE-177 Trial KEYTRUDA ® is an anti-PD-1 therapy that works by helping increase the ability of the body’s immune system to help detect and fight tumour cells. 1 An estimated 26,900 Canadians were diagnosed with colorectal cancer in 2020, with an average of 73 Canadians diagnosed daily. 2  Merck known as MSD outside the United States … Approval Based on Significant Progression Free Survival Findings from Pha...

(2) KEYTRUDA Is First Checkpoint Inhibitor Approved in Europe to Treat MSI-H or dMMR Colorectal Cancer European Approval Based on Results From KEYNOTE-177 Trial Demonstrating KEYTRUDA Significantly Reduced Risk of Disease Progression or Death by 40% Compared With Chemotherapy Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the European Commission has approved KEYTRUDA, Mercks anti-PD-1 therapy, as a monotherapy for the first-line treatment of adult pa...

Takeda Pharmaceutical Company Limited U.S. FDA Approves Supplemental New Drug Application for Takeda’s ICLUSIG® (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML Saturday, December 19, 2020 2:19PM IST (8:49AM GMT)    – Updated ICLUSIG Label will Prove Practice-Changing, Expanding Indication to CP-CML Patients with Resistance or Intolerance to At Least Two Prior Tyrosine Kinase Inhibitors (TKIs) – ­– Approval Based on Data from the Phase 2 OPTIC Trial, W...