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The agency approved a labeling update and an efficacy supplement for the oral HIF-2alpha inhibitor under the same application number, NDA215383.
Drugs@FDA (2)
The FDA's PDUFA date for zanzalintinib in metastatic colorectal cancer remains December 3, 2026, as new trials advance and guidance tightens.
SEC filing
A $6.8 billion acquisition drove a GAAP loss per share of $0.54, while Merck lifted its 2026 sales guidance and reported new approvals and trial data across oncology, HIV and cardiometabolic programs.
SEC filing