News | November 14, 2025
Hormone therapy for menopause gets green light from FDA
The FDA is initiating removal of the boxed warnings following a comprehensive review of the scientific literature
The FDA is initiating removal of the boxed warnings following a comprehensive review of the scientific literature
The UK authorization is based on positive results from the Phase III OASIS-1, -2, and -3 trials
Effective, holistic, science-backed targeted solutions for symptomatic treatment
The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo
Sleep disturbances are among the most frequent and disruptive symptoms associated with menopause which can impact women’s health and quality of life
Pivotal OASIS 1 and 2 Phase III studies of investigational compound elinzanetant achieved a statistically significant reduction in frequency and severity of vasomotor symptoms
VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause
AVT03 is a biosimilar of Amgen's Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL), which are used to treat various bone conditions
Nearly 1 in 3 HbA1c test results fall within the diabetic range, while 1 in 4 individuals show signs of prediabetes
This approval marks a significant milestone in women’s health, introducing Bayer’s first hormone-free treatment for menopause-related symptoms
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