Nuvalent Files New Drug Application for Lung Cancer Treatment With FDA

Nuvalent filed a new drug application for an experimental non-small cell lung cancer treatment with the Food and Drug Administration.
The Malaysian Reserve

Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib for the Treatment of TKI Pre-treated Patients with Advanced ROS1-positive NSCLC

NDA based on data from global ARROS-1 Phase 1/2 clinical trial FDA assigns PDUFA target action date of September 18, 2026 CAMBRIDGE, Mass., Nov. 19, 2025 ...