The U.S. Food and Drug Administration approved elinzanetant, a nonhormonal agent shown in multinational trials to reduce the frequency and severity of menopausal hot flashes and night sweats. Regulators cited randomized data supporting symptomatic benefit and an acceptable safety profile. The approval gives clinicians a nonhormonal option for vasomotor symptoms and will likely prompt rapid incorporation into women’s‑health formularies. Trial investigators included academic centers and health systems that participated in the registrational program.