Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib in TKI Pre-treated Advanced ROS1-positive NSCLC

Nuvalent; zidesamtinib; FDA acceptance; New Drug Application (NDA); ROS1-positive NSCLC; tyrosine kinase inhibitor (TKI) pre-treated; ARROS-1 trial; PDUFA date; CNS penetration; breakthrough therapy designation; orphan drug designation

Iambic’s AI-Designed HER2 Inhibitor IAM1363 Shows Early Anti-Tumor Activity in Heavily Pretreated Patients

Iambic Therapeutics; AI-designed drug; IAM1363; HER2 inhibitor; cancer; clinical trial; Phase 1/1b; ESMO 2025; brain-penetrant; tyrosine kinase inhibitor

Nuvalent Reports Positive Pivotal Data for ROS1-Targeted Lung Cancer Drug; Rolling FDA Submission Planned

Nuvalent; ROS1-positive lung cancer; zidesamtinib; FDA submission; ARROS-1 trial; NSCLC; tyrosine kinase inhibitor; objective response rate; brain metastases; oncology