The FDA cleared Bayer’s Lynkuet for treatment of menopause-related hot flashes and separately approved elinzanetant as a nonhormonal option for vasomotor symptoms. Bayer said Lynkuet is the first dual neurokinin-targeted therapy to win approval and positioned the drug as an expansion of its women’s health portfolio. Clinical trial data cited by sponsors showed meaningful reductions in hot flash frequency and severity. Regulatory approvals broaden nonhormonal therapeutic choices for menopausal patients and shift commercial focus toward neurokinin receptor modulation. Payers and clinicians will now evaluate comparative efficacy, safety and positioning versus existing hormonal and nonhormonal options.