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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 approves Perrigo's Opill (norgestrel 0.075 mg), a progestin-only daily pill, for sale over the counter, making it the first oral contraceptive Americans can buy without a prescription.

The FDA approves Sage Therapeutics' Zurzuvae (zuranolone), a 14-day course of once-daily pills and the first oral treatment for postpartum depression, while rejecting it for major depression.

Every US mammography facility must now tell patients in writing whether their breast tissue is dense, which can hide cancers on a mammogram, under the FDA's amended Mammography Quality Standards Act rule.

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 Teal Health's Teal Wand, the first device that lets women collect their own vaginal sample at home for HPV-based cervical cancer screening instead of a speculum exam.

The FDA approved Evita Solutions' 200 mg mifepristone tablets as the second generic of the abortion pill, less than two weeks after HHS promised a safety review of the drug.

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.

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.

An all-oral pairing that doubled median progression-free survival to 11.1 months from 5.5 in ESR1-mutated patients in the EMBER-3 trial. It is Inluriyo's second FDA approval in under a year.

FDA's Vaccines and Related Biological Products Advisory Committee meets virtually, 9:00 a.m. to 1:00 p.m. ET, to recommend influenza strains for the 2027 Southern Hemisphere vaccines, with a public FDA webcast.

The FDA has set 26 October 2026 as its priority-review goal date for GSK's bepirovirsen, an antisense drug aimed at a functional cure of chronic hepatitis B after two positive phase III B-Well trials.

The FDA is due to decide by 30 November 2026 whether to approve Roche's giredestrant, an oral SERD that cut the risk of recurrence or death by 30% versus standard hormone therapy in early ER-positive breast cancer.

The FDA has assigned a 6 January 2027 PDUFA target date for ImmunityBio's supplemental BLA for Anktiva plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary disease.