The FDA approved elinzanetant, a nonhormonal agent shown to reduce hot flashes and night sweats in clinical trials, and separately cleared Bayer’s Lynkuet as the first dual neurokinin-targeted therapy for menopausal vasomotor symptoms. Regulatory filings cited multinational clinical data demonstrating symptom relief and tolerability across trial populations. Sponsors presented phase III and supportive studies to regulators showing meaningful reductions in frequency and severity of vasomotor symptoms. The approvals expand nonhormonal treatment options for menopausal women and add to an increasingly competitive women’s health portfolio where large pharmas are seeking differentiated, steroid-free therapies.