Pins matching tag:Menopause

The FDA approves Astellas' Veozah (fezolinetant), a once-daily 45 mg pill and the first neurokinin 3 receptor antagonist for moderate to severe menopausal hot flashes, giving women who cannot take hormones a new option.

The FDA adds a boxed warning, its most prominent, to Astellas' hot-flash pill Veozah after a patient suffered serious liver injury within about 40 days of starting it, and orders monthly liver tests for the first months.

The FDA approves Bayer's Lynkuet (elinzanetant), the first drug to block both the NK1 and NK3 receptors, as a hormone-free treatment for moderate to severe hot flashes of menopause.

At an HHS press conference, Robert F. Kennedy Jr. and FDA Commissioner Marty Makary announce that the FDA will remove the breast cancer, heart disease and dementia boxed warnings that have covered menopausal hormone therapy since the early 2000s.

The FDA approves new labels for six menopausal hormone therapy products, one from each class, that drop the cardiovascular, breast cancer and dementia statements from the boxed warning; 29 companies have filed changes.