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 may remove the warning labels on hormone replacement therapies used to treat the symptoms of menopause. Doctors say ...

At a recent U.S. Food and Drug Administration (F.D.A.) panel, doctors argued for the removal of the black box warning on hormone treatments used to alleviate menopause symptoms. The black box warning ...