The FDA approved Lynkuet, Bayer’s once‑daily non‑hormonal oral therapy for moderate‑to‑severe vasomotor symptoms of menopause. Approval relied on three late‑stage trials that demonstrated reductions in both frequency and severity of hot flashes and night sweats. Lynkuet targets NK1 and NK3 neurokinin receptors implicated in thermoregulation; Bayer and investigators highlighted rapid symptom relief and improvements in sleep and quality of life measures. The approval positions Lynkuet as a competitor to Astellas’s Veozah, another non‑hormonal NK3‑targeting agent that has faced commercial and labeling challenges. Bayer framed Lynkuet as addressing a treatment gap for women who cannot or choose not to use hormone therapy.