The acquisition marks the company’s strategic entry into the fast-growing Hormone Replacement Therapy (HRT) segment and significantly strengthens its gynaecology portfolio in India
The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT
The FDA is initiating removal of the boxed warnings following a comprehensive review of the scientific literature
This approval marks a significant milestone in women’s health, introducing Bayer’s first hormone-free treatment for menopause-related symptoms
Five-year follow-up data from the Phase 3 ARCHES trial shows XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) reduces risk of death by 30%
Parkinson's disease (PD) is one of the most common neurological disorders caused by the death of dopamine-secreting neurons in the brain
New subgroup analysis from Phase III ARASENS trial shows that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel increased overall survival (OS)
CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%
Clears major obesity endpoints at 80 weeks
All three dose levels, 4 mg, 9 mg and 12 mg, successfully met the primary and key secondary endpoints in 80 weeks
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