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 ...
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 ...
FDA commissioner stirs debate over hormone therapy for menopause
A Food and Drug Administration expert panel has reignited a debate over whether hormone therapy should be used to treat ...
Boise State Public Radio5h
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.
The FDA May Finally Remove The Black Box Warning On Hormone Therapy Products. Here’s When It Might Happen
Hormone therapy has endured a rather bumpy history after the Women’s Health Initiative published clinical trial data in 2002 ...
Everyday Health on MSN3d
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 ...
Healio8d
FDA panel calls for label changes, more education on menopausal hormone therapy
Members of an FDA expert panel discussed reassessing boxed warnings for menopausal HT and how to better educate patients and ...
FDA panel to revisit menopausal hormone therapy
MENOPAUSAL THERAPY IN FOCUS — The FDA will hold a panel discussion Thursday on hormone therapy for menopausal women, a pet ...
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 […] ...
BioPharma Dive7d
Panel urges FDA to remove warnings on hormonal menopause therapy
A meeting held by the FDA Thursday spotlighted debate over black box warnings that have limited use of hormone treatment for ...
Managed Healthcare Executive8d
FDA Panel Challenges Hormone Replacement Therapy Risks
A panel of 12 experts in the menopause field reexamined the findings of the 2002 Women’s Health Initiative study that said ...