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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 ...
U.S. Food and Drug Administration Commissioner Marty Makary said he is focused on overhauling long-held standards and ...
The FDA may remove the warning labels on hormone replacement therapies used to treat the symptoms of menopause. Doctors say ...
An unusual FDA panel on antidepressant use during pregnancy elevated clinicians and researchers who are deeply skeptical of ...
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