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.

After losing 3,500 employees in April—19% of its workforce due to congressional budget cuts—the FDA is now struggling to meet ...

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

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 ...

The US Food and Drug Administration (FDA) has notified Bayer that it 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 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 ...

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.