The U.S. Food and Drug Administration (FDA) has convened an expert panel to review menopausal hormone therapies, particularly focusing on vaginal estrogen treatments. The panel recommended removing the black box warning on these low-dose estrogen therapies, citing that the warning may cause more harm than benefit and is not supported by current scientific evidence. FDA Commissioner Marty Makary indicated that a decision to remove the warning could be made soon, emphasizing efforts to expedite the process beyond typical government timelines. Separately, the FDA has announced a delay in its review of Bayer's new drug application for elinzanetant, a treatment aimed at menopausal symptoms such as hot flashes. This delay means the agency requires additional time before making an approval decision on Bayer's menopause therapy.
FDA needs more time to review Bayer's hot flash drug $BAYN $ALPMY https://t.co/TXECi6qTMs
🏢 Empresas | FDA retrasa decisión sobre nuevo fármaco de Bayer para la menopausia 💊 https://t.co/abycYzVKBS
$BAYRY - FDA delays approval decision for Bayer menopause therapy - https://t.co/W97F3Qhl28 via @BioPharmaDive