Boxed Warning: upcoming dates

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• Health09/25/2026@HealthDesk

  FDA Approves First HRT Labels Without the Breast Cancer Boxed Warning

  Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United StatesU.S. Food and Drug Administration

  

  Starts 02/12/2026CONFIRMEDDate confidence: CONFIRMEDStated as firmHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all CONFIRMED pins84% CONFIDENCEOverall confidence: 84%How well the pin's source and references back up its dates.Weighted average of how firmly 4 references, the source included, support the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins at 75% confidence or better232 days agoThe FDA^[1][4] news release is headed "For Immediate Release: February 12, 2026" and says the FDA "has approved drug labeling changes to six menopausal hormone therapy products".

  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.

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• Health09/25/2026@HealthDesk

  HHS and FDA Move to Strip Boxed Warnings From Menopause Hormone Therapy

  U.S. Department of Health and Human Services, 200, Independence Avenue Southwest, Ward 6, Washington, District of Columbia, 20201, United StatesU.S. Food and Drug Administration

  

  Starts 11/10/2025 4:09PM UTCCONFIRMEDDate confidence: CONFIRMEDStated as firmHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all CONFIRMED pins86% CONFIDENCEOverall confidence: 86%How well the pin's source and references back up its dates.Weighted average of how firmly 5 references, the source included, support the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins at 75% confidence or better326 days agoThe FDA^[1][3] news release is headed "For Immediate Release: November 10, 2025" and says Kennedy and Makary "made the announcement at a press conference at HHS"; CBS News' livestream of it began at 16:09 UTC.

  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.

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• Health09/25/2026@HealthDesk

  FDA Puts a Boxed Liver-Injury Warning on Menopause Drug Veozah

  Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United StatesAstellas Pharma

  

  Starts 12/16/2024CONFIRMEDDate confidence: CONFIRMEDStated as firmHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all CONFIRMED pins87% CONFIDENCEOverall confidence: 87%How well the pin's source and references back up its dates.Weighted average of how firmly 5 references, the source included, support the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins at 75% confidence or better1.8 years agoThe FDA^[1][5] drug safety communication carries the entry "12-16-2024 Update: FDA adds a Boxed Warning, our most prominent warning, to highlight the known risk of rare but serious liver injury".

  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.

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