FDA Approves Labeling Changes to Menopausal Hormone Therapy Products

https://www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products?utm_medium=email&utm_source=govdelivery The U.S. Food and Drug Administration has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT), to clarify risk considerations for these drugs. Specifically, risk statements related to cardiovascular disease, breast cancer and probable dementia were removed from the “boxed warning,” the agency’s most prominent safety-related warning. “This decision reflects our commitment to follow the science wherever it leads and to correct course when the evidence demands it,” Health and Human Services Secretary Robert F. Kennedy, Jr. said. “By removing these boxed warnings, we ensure that women receive accurate information about hormone therapy—free from exaggeration or fear. A healthcare system worthy of public trust tells the truth, updates its guidance as science evolves, and respects women’s ability to make informed choices about their own health.” The FDA initiated the removal of these warnings in November 2025, following a comprehensive review of the scientific literature. At the FDA’s request, 29 drug companies have submitted proposed labeling changes. This first batch of six products with approved labeling changes includes products from each of the four categories of HRT for menopausal women: Systemic combination therapy (estrogen and progestogen) Systemic estrogen-alone therapy Systemic progestogen-alone therapy for women with a uterus using systemic estrogen Topical vaginal estrogen therapy “With today’s action, we are delivering on our promise to make sure women have accurate, scientifically grounded information about the potentially life-changing benefits of HRT,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Women face symptoms of menopause that can last for years, and our efforts will help these women make well-informed medical decisions.” Menopause is a normal life stage, but its symptoms can significantly reduce quality of life. Common symptoms include hot flashes and night sweats (called vasomotor symptoms or VMS); vaginal, vulvar, and urinary tract changes caused by lower estrogen levels; and osteoporosis (thinning bones), which increases fracture risk. The FDA has approved multiple hormone therapies for moderate-to-severe hot flashes, vaginal dryness and discomfort, and preventing bone loss. In addition, randomized studies show that women who initiate HRT within 10 years of the onset of menopause (generally before age 60) have a reduction in all-cause mortality and fractures. Just a small fraction of women who could benefit from these treatments, however, are using them. In 2020, about 41 million U.S. women were ages 45–64 — yet only about 2 million women ages 46–65 received a hormone-therapy prescription. Today’s action will allow women, working with their health care professionals, to make better-informed decisions about their treatment plan for menopause symptoms. Women are encouraged to consult the drug label, available here, for more detailed information about the benefits and risks of these products. Menopausal Hormone Therapies with Updated Prescribing Information https://www.fda.gov/drugs/drug-safety-and-availability/menopausal-hormone-therapies-updated-prescribing-information?utm_medium=email&utm_source=govdelivery

Statin safety: when warnings outlive the evidence The Lancet ++... ´+

Statin safety: when warnings outlive the evidence The Lancet https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00303-X/fulltext?dgcid=raven_jbs_etoc_email Feb 14, 2026 Volume 407Number 10529p649-732 https://www.thelancet.com/journals/lancet/issue/vol407no10529/PIIS0140-6736(26)X2004-9 Tetanus Prof Önder Ergönül, MD MPHa,b oergonul@ku.edu.tr ∙ Selin Kolsuz, MDa ∙ Prof J Peter Figueroa, MBBS PhD https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01579-X/abstract?dgcid=raven_jbs_etoc_feature_lancet

Thawing a Frozen Shoulder Arif Musa, MD; Ali Harb, MD | February 4, 2026 |

https://reference.medscape.com/slideshow/Frozen-Shoulder-6019131?ecd=wnl_critimg_260213_mscpref_etid8099014&uac=148436CN&impID=8099014 Frozen shoulder is a condition marked by progressive stiffness and pain that eventually resolves through a "thawing" phase. While traditional treatments range from physical therapy to surgery, new techniques like Adhesive Capsulitis Embolization (ACE) offer additional relief. This presentation reviews current treatment efficacy and new clinical developments.

Alcohol guidance in US dietary guidelines: a step backwards The Lancet Gastroenterology & Hepatology ++... ++

https://www.thelancet.com/journals/langas/article/PIIS2468-1253(26)00016-6/fulltext?dgcid=raven_jbs_etoc_email Mar 2026 Volume 11Number 3p175-266, e2-e5 https://www.thelancet.com/journals/langas/issue/vol11no3/PIIS2468-1253(26)X2001-5 Definitions, diagnosis, management, and outcomes of upper gastrointestinal Crohn's disease: an international, expert RAND/UCLA appropriateness study Nathaniel A Cohen, MDa nathanielac@tlvmc.gov.il ∙ Prof Dominik Bettenworth, MDb,c ∙ Neta Sror, MDd ∙ Raneem Khedraki, PhDe ∙ Qijun Yang, MSe ∙ Prof Maria T Abreu, MDf ∙ et al. https://www.thelancet.com/journals/langas/article/PIIS2468-1253(25)00347-4/abstract?dgcid=raven_jbs_etoc_feature_langas Appendicectomy versus switching to a JAK inhibitor in inducing remission in patients with active ulcerative colitis after biologic therapy failure (COSTA): 1-year results of a multicentre, prospective, cohort study Eva Visser, MD PhDa ∙ Maud A Reijntjes, MD PhDa ∙ Lianne Heuthorst, MD PhDa ∙ Merle E Stellingwerf, MD PhDa ∙ Rachel West, MD PhDb ∙ Koen van Dongen, MD PhDc ∙ et al. https://www.thelancet.com/journals/langas/article/PIIS2468-1253(25)00291-2/abstract?dgcid=raven_jbs_etoc_feature_langas

Editorial e75 GLP-1 receptor agonists in rheumatic disease The Lancet Rheumatology ++... +

Assessing clinical and cost effectiveness of total versus partial knee replacement (TOPKAT): 10-year follow-up of a multicentre, randomised controlled trial Prof David J Beard, DPhila,d david.beard@ndorms.ox.ac.uk ∙ Loretta J Davies, DPhila ∙ Prof Jonathan A Cook, PhDa ∙ Prof Graeme MacLennan, MScc ∙ Jemma Hudson, PhDc ∙ Prof Andrew J Price, FRCSa ∙ et al. https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(25)00250-4/fulltext?dgcid=hubspot_update_feature_updatealerts_lanrhe&utm_campaign=update-lanrhe&utm_medium=email&_hsenc=p2ANqtz-8EvPIK-fX0yJMuYr9c9Nwpm9DIZRxFz0gOGNEBqrxbEH7fNoROnm7ue3Totl3pYHkiyW_KNOoBIDS2jgAY5gRQeicV4w&_hsmi=403170350&utm_content=402699227&utm_source=hs_email Editorial e75 GLP-1 receptor agonists in rheumatic disease The Lancet Rheumatology https://www.thelancet.com/journals/lanrhe/issue/vol8no2/PIIS2665-9913(26)X2001-X Trends in mortality due to haemophagocytic lymphohistiocytosis across 29 European countries from 2011 to 2021: a retrospective, international, population-based study Leher Gumber, MSca,b ∙ Reza Omidvar, MScc ∙ Francesca Gonnelli, PhDd,e ∙ Adam Taylor, MEngc ∙ Thomas Trimble, BScc ∙ Mark Bishton, PhDe,f ∙ et al. https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(25)00292-9/fulltext?dgcid=hubspot_update_feature_updatealerts_lanrhe&utm_campaign=update-lanrhe&utm_medium=email&_hsenc=p2ANqtz-9aoZkd0o9FGb_nWrlnoJRWFpic0JTPGPQ8_H80f5KTTSL4xH3EWoRoQCgcTqDH1rl4l3LjAYNXar7gys7ODjs8TLebRw&_hsmi=403170350&utm_content=402699227&utm_source=hs_email

Gene therapy startups push past old limits to reach more patients With gene therapy now a clinical reality, innovators are designing delivery systems that can sustain lifelong correction, handle complex genes, and make treatments accessible to more patients. +++++

https://www.drugdiscoverynews.com/gene-therapy-startups-push-past-old-limits-to-reach-more-patients-17003 In 2026, drug discovery faces a higher bar Biopharma’s recovery is real, but the data show a sector that now rewards validated biology, late-stage execution, and commercial relevance. https://www.drugdiscoverynews.com/in-2026-drug-discovery-faces-a-higher-bar-16997 A faster route to active GPCRs GPCRs drive a huge portion of today’s drug market, but producing them in a functional form remains a major bottleneck for discovery and structural studies. https://www.drugdiscoverynews.com/a-faster-route-to-active-gpcrs-16977 Exploring the tiny robots improving drug delivery from inside the body Moved by magnets or ultrasound waves, these tiny robots make delivering drugs more accurate and effective. https://www.drugdiscoverynews.com/exploring-the-tiny-robots-improving-drug-delivery-from-inside-the-body-16998 Sustained-release drug delivery targets pediatric inherited retinal disease PolyActiva and RareSight are pairing pro-drug chemistry with targeted ocular delivery to address early-stage barriers in rare pediatric retinal disorders. https://www.drugdiscoverynews.com/sustained-release-drug-delivery-targets-pediatric-inherited-retinal-disease-16945

Highlights From the Annual Neuro-Oncology Conference: Integrating IDH Inhibitor Therapy Into Glioma Care Authors: Maciej Mrugala, MD, PhD, MPH; Rimas V. Lukas, MD; Yoshie Umemura, MD

https://www.medscape.org/viewarticle/1003175?sso=true&uac=148436CN&src=mkmcmr_driv_stan_mscpedu_260212-OUS-HONC-1003175-cta