The extended review for Elinzanetant is supported by data from the Phase III OASIS 1, 2, and 3 trials, which supported the ...

Barclays (LON: BARC) views the development as “a small negative for Bayer,” though analysts remain positive on the drug’s ...

The Food and Drug Administration (FDA) has extended the review period for elinzanetant, an investigational hormone-free therapy for the treatment of moderate to severe vasomotor symptoms (VMS) due to ...

Bayer Provides Regulatory Update on Elinzanetant for the Treatment of Moderate to Severe Hot Flashes Due to Menopause ...

Bayer (OTCPK:BAYZF) (OTCPK:BAYRY) (OTCPK:BAMXF) said it has received notification from the FDA regarding an extension of the ...

The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...

The U.S. Food and Drug Administration has extended its review of Bayer's experimental menopause relief drug, the German ...

After losing 3,500 employees in April—19% of its workforce due to congressional budget cuts—the FDA is now struggling to meet ...

Elinzanetant significantly reduced vasomotor symptoms (VMS), also known as hot flashes, associated with menopause overall and across a range of body mass index (BMI) and smoking history subgroups ...

Once-daily oral elinzanetant was associated with significantly reduced frequency of moderate to severe menopausal vasomotor symptoms compared with placebo, according to topline results from the ...

Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen ...

Elinzanetant, the first dual neurokinin-1,3 (NK-1,3) receptor antagonist, modulates the KNDy neurons, a group of estrogen sensitive neurons in the hypothalamus region of the brain.