News

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 ...
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 ...
Healio6d
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 MSN1d
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 could benefit.
Managed Healthcare Executive6d
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 ...
BizPac Review1d
‘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 […] ...
Science News5d
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.
How one controversial study shaped 20 years of menopause care
Hone Health reports that the controversial 2002 WHI study misled menopause care, linking HRT to breast cancer and causing ...
FiercePharma1y
Another delay for Ascendis' hormone therapy as FDA extends review by 3 ...
It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide). And, now, it’ll take another three months for the U.S ...
Reuters1y
US FDA extends review of Ascendis Pharma's hormone disorder therapy
The U.S. Food & Drug Administration has extended its review of Ascendis Pharma's therapy to treat adult patients with a hormone disorder by three months, the company said on Tuesday.