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.

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 ...

These two Food and Drug Administration-approved drugs for cancer treatment may hold the key to reversing Alzheimer's disease ...

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

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 ...

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 ...

Establish a good sleep routine — consider trying a warm Epsom salt bath with lavender, a cup of chamomile or hibiscus tea, ...

Combination therapy — pairing androgen deprivation therapy (ADT) with FDA-approved oral agents — has become a widely used ...

When perimenopause or menopause begins, you may focus on symptoms like hot flashes, night sweats or mood changes. At the very ...

Perimenopause symptoms vary greatly for each individual, and there are many options available for women who are struggling with life’s transition into menopause.