unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC), and unresectable or advanced hepatocellular carcinoma (HCC) 1. This dual ...
Based on the Phase 3 CheckMate-9DW trial, Opdivo plus Yervoy demonstrated a statistically significant overall survival benefit compared to investigator’s choice of lenvatinib or sorafenib 1 In the ...
FDA approves Opdivo and Yervoy for unresectable or metastatic MSI-H/dMMR colorectal cancer in patients 12 and older. Opdivo's accelerated approval for single-agent use in MSI-H/dMMR metastatic CRC is ...
The U.S. Food and Drug Administration (FDA) on Tuesday approved Bristol Myers Squibb & Co’s (NYSE:BMY) Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment of adult and pediatric ...
A Prescription Drug User Fee Act target date of June 23, 2025 has been set for the application. The sBLA is supported by data from the randomized, open-label phase 3 CheckMate 8HW trial ...
On Friday, the European Commission (EC) approved Bristol Myers Squibb & Co’s (NYSE:BMY) Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or ...
The risk of disease progression or death was reduced by 79% with nivolumab/ipilimumab compared with chemotherapy. The Food and Drug Administration (FDA) has approved Opdivo ® (nivolumab) in ...
Bristol Myers Squibb Presents Results from CheckMate -8HW Analysis Evaluating Opdivo® (nivolumab) plus Yervoy® (ipilimumab) Compared to Opdivo Monotherapy in Patients with Microsatellite ...
The FDA accepted a supplemental biologics license application for Opdivo plus Yervoy as a first-line treatment for some adult and pediatric patients with colorectal cancer. The Food and Drug ...
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