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

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 ...

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

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

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

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 ...

Panelists discuss the methodologies of the OASIS 1, 2, and 3 trials that investigated elinzanetant, highlighting key findings regarding its efficacy in reducing the frequency and severity of ...

The US Food and Drug Administration (FDA) has notified Bayer that it has extended the review period for the New Drug ...

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 ...

Elinzanetant was associated with fewer and less severe menopausal vasomotor symptoms over 12 weeks. The neurokinin-1,3 receptor antagonist was associated with improved sleep and quality of life vs ...

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.