The FDA granted Bayer label expansion for Hyrnuo (sevabertinib), shifting the company’s HER2-mutated NSCLC drug further into earlier-line care. After an accelerated approval last November for previously treated patients, the agency now allows first-line use in adults with locally advanced or metastatic nonsquamous disease bearing HER2 tyrosine kinase domain activating mutations. For Bayer, the move extends a fast-moving HER2 targeted segment in lung cancer and sets a new benchmark for clinical adoption in the frontline setting. It also increases the relevance of HER2 mutation testing workflows as clinicians decide between targeted options before chemotherapy choices crystallize. The FDA’s decision arrives amid heightened attention to how targeted oncology drugs are evaluated across lines of therapy, especially when approval pathways already rely on earlier-stage evidence. The label broadening may affect trial design, biomarker strategies, and competitive positioning among HER2-directed regimens. Separately, Echo IQ reported an FDA setback for its AI-based heart failure clinical decision support software, with the agency issuing a not substantially equivalent determination for the company’s initial 510(k) application for Echosolv HF. The outcome delays U.S. clearance plans for the diagnostic ambition.