The FDA moved to expand access for Bayer’s Hyrnuo (sevabertinib) in HER2-mutated lung cancer, granting an accelerated approval expansion to first-line patients with locally advanced or metastatic nonsquamous disease. The label expands the drug’s previously approved use in later-line settings and underscores regulators’ continued reliance on accelerated pathways for targeted oncology. Separately, radioembolization technology faced an important clinical setback: a trial reported that balloon catheters did not improve tumor targeting in patients receiving holmium-166 radioembolization, challenging a key device-adjunct strategy intended to increase delivery precision. Taken together, the updates highlight both opportunity and risk in oncology—regulatory expansions can widen the window for precision medicines, while device modifications aimed at improving delivery may still fail to translate into better targeting outcomes.