FDA Delays Approval Decision for Bayer Menopause Therapy

FDA delays approval decision for Bayer menopause therapy

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.

FDA delays decision date on Bayer’s hot flash treatment by up to three months

Bayer said the FDA has extended its review of the company’s hot flash treatment by up to three months. The FDA concluded that it needs additional time to review the nonhormonal drug elinzanetant, the German ...

FDA extends review period for Bayer's elinzanetant for vasomotor symptoms

"The FDA did not raise any concern regarding the general approvability of elinzanetant in its correspondence," according to an anouncement from Bayer.