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.

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

Bayer (OTCPK:BAYZF) (OTCPK:BAYRY) (OTCPK:BAMXF) said it has received notification from the FDA regarding an extension of the ...

Astellas’ menopause treatment has been accepted for FDA review, five months after the therapy hit a speed bump in a phase 3 trial conducted in Asia.

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

Members of an FDA expert panel discussed reassessing boxed warnings for menopausal HT and how to better educate patients and ...

Hormone therapy has endured a rather bumpy history after the Women’s Health Initiative published clinical trial data in 2002 ...

The debate over whether to use hormone therapy to treat menopausal women continues, as a Food and Drug Administration (FDA) expert panel weighs in. The panel, consisting […] ...

A panel of 12 experts in the menopause field reexamined the findings of the 2002 Women’s Health Initiative study that said ...

Hone Health reports that the controversial 2002 WHI study misled menopause care, linking HRT to breast cancer and causing ...

Experts worry the warning on vaginal estrogen menopause treatments is doing more harm than good and is not supported by science.

Bioidentical or plant-derived hormones have uncertain efficacy or safety in treating menopausal symptoms. What is the evidence supporting the use of compounded and FDA-approved bioidentical products?