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 ...
Bayer's Elinzanetant review period gets extended by FDA
Bayer (OTCPK:BAYZF) (OTCPK:BAYRY) (OTCPK:BAMXF) said it has received notification from the FDA regarding an extension of the ...
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 ...
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 ...
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 ...
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 […] ...
FierceBiotech2y
Astellas' menopause therapy accepted for FDA review - Fierce Biotech
Astellas’ menopause treatment has been accepted for FDA review, five months after the therapy hit a speed bump in a phase 3 trial conducted in Asia.
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 ...
Oprah Daily on MSN8d
The FDA Is Meeting Today About the Future of a Key Menopause Treatment
A decades-old label has scared women (and their doctors) away from safe and effective menopause treatment. That could finally change today.
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 ...
Science News7d
U.S. FDA may nix black box warning on some menopause estrogen treatments
Experts worry the warning on vaginal estrogen menopause treatments is doing more harm than good and is not supported by science.
Becker's Hospital Review7y
FDA OKs hormone therapy for vaginal condition tied to menopause: 4 ...
The FDA approved TherapeuticsMD’s hormone therapy Imvexxy for a vaginal condition linked to low estrogen levels during menopause, the company announced May 30. 1. Imvexxy is intended to treat ...