The FDA has accepted a new drug application for gedatolisib, an investigational PI3K and mTOR inhibitor for treating certain patients with advanced cancer.
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FDA Oncology Update January 2026: New Horizons in Precision Medicine | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways
PI3K And MTOR Inhibitor Drug type
Advanced Cancer Patients Target indication
August 30, 2026 PDUFA date