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 ...
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 ...
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 ...
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 […] ...
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 ...
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Winona Menopause Review - Is It Worth It For Hormone Therapy (HRT)? - MSN
Winona is a telehealth company that offers hormone replacement therapy (HRT) for menopause. The company provides FDA-approved bioidentical HRT treatments, which have been found to provide relief ...
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.
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 ...
AOL1y
US FDA extends review of Ascendis Pharma's hormone disorder therapy - AOL
(Reuters) -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. U ...