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

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

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

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 ...

US FDA extends review period for Bayer’s NDA for elinzanetant to treat moderate to severe VMS due to menopause: Berlin Monday, July 28, 2025, 16:00 Hrs [IST] Bayer announced tha ...

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

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 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 ...