25 July 2025 - Bayer today announced that the US FDA has notified the company that it has extended the review period for the new drug application for elinzanetant, the first neurokinin 1 and neurokinin 3 receptor antagonist for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) due to menopause.

The FDA has determined additional time is needed for a full review of the new drug application submission, including information provided to support the application. The extension to the PDUFA review period is up to 90 days.

Read Bayer press release