News

FDA delays approval decision for Bayer menopause therapy
The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...
WSKG4h
Doctors urge FDA to remove black box warning on hormone therapy for menopause
The FDA may remove the warning labels on hormone replacement therapies used to treat the symptoms of menopause. Doctors say ...
Bayer's elinzanetant review period gets extended by FDA
Bayer announced an FDA review extension for Elinzanetant, its experimental menopausal hot flash therapy. Approval remains on track. REad more here.
Iowa Public Radio9h
Warning labels on menopause treatments 'scare women,' doctors tell the FDA
The FDA may remove the warning labels on hormone replacement therapies used to treat the symptoms of menopause. Doctors say ...
The Highland County Press10h
FDA 'rewriting' food pyramid guidelines
U.S. Food and Drug Administration Commissioner Marty Makary said he is focused on overhauling long-held standards and ...
MedPage Today1d
FDA 'Expert Panels' Raise Concerns of Evading Regulations, Ethics
Bypassing its standard pathways for scientific discussions, FDA has recently held a slew of so-called "expert panels" that ...
Black box warning on menopause hormone therapies should be removed, experts say
Hormone therapies for menopause have come with black box warnings for decades. Our wellness expert explains why this could ...
Everyday Health3d
New FDA Panel Recommends Removing Warnings From Estrogen Therapies for Menopause
The panelists said that vaginal creams and other localized therapies for menopause are safe and vastly underused by women who ...
BizPac Review3d
‘All of us are begging’: New push for FDA to remove ‘black box’ warnings from menopause products
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 […] ...
FDA commissioner stirs debate over hormone therapy for menopause
A Food and Drug Administration (FDA) expert panel has reignited a debate over whether hormone therapy should be used to treat ...