The U.S. Food and Drug Administration has extended its review timeline for Bayer’s non-hormonal menopause treatment, elinzanetant, citing a need for additional data. While regulators in Canada and the U.K. have approved the therapy, the FDA’s delay indicates further scrutiny on this hot flash drug’s safety and efficacy profile. Bayer anticipates a three-month review extension, reflecting the agency’s cautious approach amid competitive menopause treatment options.