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 ...

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

FDA delays Bayer’s elinzanetant review to Oct 2025 amid liver safety concerns; global approvals still on track.

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

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

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 ...

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Berlin: Bayer has announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug ...

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

The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and the U.K. have already cleared it for use.

Bayer announced an FDA review extension for Elinzanetant, its experimental menopausal hot flash therapy. Approval remains on track. REad more here.

Bayer said the Food and Drug Administration extended the review period for its new drug application of elinzanetant, a treatment for moderate to severe vasomotor symptoms, also known as hot flashes, ...