US FDA approves Bayer's menopause relief drug

October 24, 2025 1:35 PM EDT

The logo of Bayer Mexico is pictured at the company's plant in Lerma, Mexico November 10, 2022. REUTERS/Henry Romero

(Reuters) -Germany's Bayer said on Friday the U.S. health regulator has approved its drug for menopause relief.

The drug, branded as Lynkuet, is a non-hormonal treatment designed to relieve moderate-to-severe vasomotor symptoms, also known as hot flashes, associated with menopause.

The U.S. Food and Drug Administration's approval was based on three late-stage studies that showed Lynkuet reduced the frequency and severity of hot flashes and eased sleep disturbances in menopausal women.

The regulator had in July extended the review of the drug, but did not raise any concerns regarding its general approvability.

(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shilpi Majumdar)



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