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The FDA approved Bayer’s non-hormonal drug Lynkuet for moderate-to-severe menopausal hot flashes, available November 2025.
The U.S. FDA has approved Bayer’s non-hormonal drug Lynkuet for treating moderate-to-severe hot flashes in menopausal women, based on results from three late-stage trials.
The once-daily capsule, to be taken at bedtime, reduces symptom frequency and severity and improves sleep.
Approved on October 24, 2025, it is expected to launch in November with a $625 monthly wholesale price, though patient costs may be as low as $25 through Bayer’s support program.
The drug carries warnings for drowsiness, liver enzyme elevation, pregnancy loss, and seizures in those with epilepsy, and grapefruit should be avoided.
Lynkuet is already approved in several countries and joins Veozah as one of the few non-hormonal oral treatments for menopausal hot flashes in the U.S.
La FDA aprobó el medicamento no hormonal Lynkuet de Bayer para los sofocos de menopausia de moderados a severos, disponible en noviembre de 2025.