This strategic collaboration represents the third clinical trial under Senhwa’s five-year NCI-sponsored cancer research program
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
The safety profile of Opdualag observed in this analysis was consistent with the known profiles of nivolumab and relatlimab
The companies have initiated Phase 3 studies in patients with high-risk melanoma and non-small cell lung cancer
Data showed that the primary endpoint of recurrence-free survival (RFS) met the pre-specified futility criteria
Receives 3 final and 2 tentative product approvals thus far in Q1FY25
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy
BioNTech's diverse pipeline includes multiple drugs in Phase I, II, and III clinical trials
Sun Pharma will have exclusive rights to commercialise Nidlegy for indications of skin cancers in the territories of Europe, Australia and New Zealand. Philogen will complete pivotal clinical trials for the product in Europe
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