Recent developments in regulatory approvals are reshaping the oncology and diagnostic landscape. The FDA approved the Oncomine Dx Express assay as a companion diagnostic (CDx) for Dizal’s Zegfrovy, enabling precision treatment of non-small cell lung cancer patients with EGFR exon 20 insertion mutations. Regeneron's bispecific antibody drug Lynozyfic (linvoseltamab) gained accelerated FDA approval for relapsed and refractory multiple myeloma, offering dosing flexibility. Additionally, Qlucore secured CE-IVD marking for its acute lymphoblastic leukemia test and plans further expansion of its molecular diagnostic portfolio. These approvals underline the growing integration of innovative diagnostics and targeted therapies in clinical oncology.