The U.S. FDA approved Bayer’s oral HER2‑directed therapy Hyrnuo (sevabertinib) for adults with advanced HER2‑mutant non‑small‑cell lung cancer after prior systemic therapy. The approval relies on clinical data for tumors with ERBB2 tyrosine kinase domain activating mutations and comes with breakthrough and priority review designations earlier in the year. Thermo Fisher Scientific secured FDA clearance for an NGS companion diagnostic to identify eligible patients for Hyrnuo, enabling a genomic testing pathway for clinicians. Together the approvals align a targeted medicine with a validated molecular test, tightening the diagnostic‑therapy linkage that shapes patient selection and commercial uptake.