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.

Coronary artery calcium testing can reveal plaque in arteries, offering a more precise estimate of a patient’s risk. Yet the ...

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