The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and the U.K. have already cleared it for use.

The FDA has extended the review period for elinzanetant for the treatment of moderate to severe vasomotor symptoms due to menopause.

Nearly half of women in the U.S. going through menopause may experience moderate to severe vasomotor symptoms due to ...

The U.S. Food and Drug Administration has extended its review of Bayer's experimental menopause relief drug, the German company said on Friday.

There’s no cure for Alzheimer’s yet, but scientists may be getting closer using an unlikely tool … cancer drugs. Researchers ...

Berlin: Bayer has announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug ...

Bayer Provides Regulatory Update on Elinzanetant for the Treatment of Moderate to Severe Hot Flashes Due to Menopause ...

The US Food and Drug Administration (FDA) has notified Bayer that it has extended the review period for the New Drug ...

The panelists said that vaginal creams and other localized therapies for menopause are safe and vastly underused by women who ...

A Food and Drug Administration (FDA) expert panel has reignited a debate over whether hormone therapy should be used to treat ...

US FDA extends review period for Bayer’s NDA for elinzanetant to treat moderate to severe VMS due to menopause: Berlin Monday, July 28, 2025, 16:00 Hrs [IST] Bayer announced tha ...

The U.K.’s health regulator has signed off on Bayer’s Lynkuet, an oral treatment to relieve moderate to severe hot flashes that accompany menopause.