健康2026/09/25@HealthDesk
HHS and FDA Move to Strip Boxed Warnings From Menopause Hormone Therapy
U.S. Food and Drug AdministrationU.S. Department of Health and Human Services, 200, Independence Avenue Southwest, Ward 6, Washington, District of Columbia, 20201, United States
开始于 2025/11/10 16:09已确认可信度 86%319天前The 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.
0.78
健康2026/09/25@HealthDesk
FDA Decision Due on Roche's Giredestrant for Early Breast Cancer
RocheMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
开始于 2026/11/30已排期可信度 78%66天后Roche's^[1] release says "The FDA is expected to make a decision on the approval by 30 November 2026", the PDUFA goal date set under Priority Review.
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.
0.72
健康2026/09/25@HealthDesk
FDA Approves Opill, the First US Birth Control Pill Without a Prescription
PerrigoMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
开始于 2023/07/13已确认可信度 90%3.2年前The FDA^[1] news release is headed "For Immediate Release: July 13, 2023" and says "Today, the U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use".
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.
0.70
健康2026/09/25@HealthDesk
FDA Approves Bayer's Lynkuet, a Dual NK1/NK3 Hot-Flash Pill
BayerMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
开始于 2025/10/24 17:25已确认可信度 87%336天前Bayer's^[1] release is stamped "24 October 2025 | 19:25 PM Europe/Amsterdam" and opens "Berlin, October 24, 2025 - Bayer announced today that the U.S. Food and Drug Administration (FDA^[2]) has approved elinzanetant".
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.
0.70
健康2026/09/25@HealthDesk
FDA Approves Veozah, the First Non-Hormonal NK3 Pill for Hot Flashes
Astellas PharmaMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
开始于 2023/05/12已确认可信度 90%3.4年前The FDA^[1][2][3] news release is headed "For Immediate Release: May 12, 2023" and says "Today, the U.S. Food and Drug Administration approved Veozah (fezolinetant)".
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.
0.69
健康2026/09/23@HealthDesk
礼来向 FDA 提交 retatrutide 上市申请
Eli LillyEli Lilly and Company Corporate Center, East McCarty Street, Indianapolis, Indiana 46206, United States
开始于 2027/03/31预估延期3个月可信度 77%187天后礼来“计划随后于 2027 年第一季度提交 retatrutide 的美国上市申请”——未给出具体日期，因此本条目取 2027 年第一季度的最后一天。^[1]
礼来计划在完成生产数据包后，于 2027 年第一季度向 FDA 提交 retatrutide 的生物制品许可申请；这款三重激素减重针剂在三期试验中最多使体重下降 28.3%。
0.67
健康2026/09/25@HealthDesk
FDA Approves Teal Wand, the First At-Home Cervical Cancer Screening Kit
Teal HealthMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
开始于 2025/05/09 14:33已确认可信度 85%1.4年前The release is datelined "SAN FRANCISCO, May 9, 2025", stamped 10:33 ET, and says Teal Health "today announced the Food and Drug Administration's (FDA) approval of the Teal Wand".^[1]
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.
0.67
健康2026/09/25@HealthDesk
FDA Rule Requiring Breast Density Notices With Every Mammogram Takes Effect
U.S. Food and Drug AdministrationMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
开始于 2024/09/10已确认可信度 89%2年前The FDA^[1] page says "Enforcement of the MQSA regulations as amended by the 2023 MQSA Final Rule began on September 10, 2024"; the rule has no end date, so the period is open-ended.
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.
0.67
法律2026/09/25@LawDesk
Supreme Court Rejects Challenge to Mifepristone in FDA v. Alliance
Supreme Court of the United StatesSupreme Court of the United States, 1, 1st Street Northeast, Ward 6, Washington, District of Columbia, 20543, United States
开始于 2024/06/13已确认可信度 84%2.3年前The slip opinion in No. 23-235 is headed "Argued March 26, 2024—Decided June 13, 2024".^[1]
A unanimous Supreme Court threw out anti-abortion doctors' challenge to the FDA's rules for the abortion pill mifepristone, holding they had no standing to sue, so mail and telehealth access stayed in place.
0.66
健康2026/09/23@HealthDesk
FDA 批准雅培 Libre Duo 血糖-酮体传感器
Abbott Laboratories1360 South Loop Road, Alameda, Alameda County, California, 94502, United States
开始于 2026/08/25已确认可信度 87%31天前新闻稿落款为“伊利诺伊州雅培园，2026 年 8 月 25 日”，称雅培“今天宣布其 Libre Duo 10 Day 系统获得美国食品药品监督管理局（FDA^[2][3]）批准”；FDA 的 De Novo 记录给出相同的决定日期 08/25/2026。
FDA 批准雅培的 Libre Duo 10 Day，这是首款同时连续监测血糖和酮体的可穿戴设备，可在发生糖尿病酮症酸中毒之前提醒 2 岁及以上的糖尿病患者酮体正在升高。
0.66
健康2026/09/25@HealthDesk
FDA Approves Zurzuvae, the First Pill for Postpartum Depression
Sage TherapeuticsMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
开始于 2023/08/04已确认可信度 89%3.1年前The FDA^[1] news release is headed "For Immediate Release: August 04, 2023" and says "Today, the U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression".
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.
0.66
健康2026/09/25@HealthDesk
FDA Puts a Boxed Liver-Injury Warning on Menopause Drug Veozah
Astellas PharmaMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
开始于 2024/12/16已确认可信度 87%1.8年前The 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.
0.65

The 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".

开始: 2026年2月12日可信度 90%来自来源

FDA Approves First HRT Labels Without the Breast Cancer Boxed Warning

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.

On 12 February 2026 the FDA approved labeling changes for six menopausal hormone therapy (HRT) products, removing cardiovascular disease, breast cancer and probable dementia from their boxed warnings^[1][3]
The first batch covers all four HRT categories: systemic oestrogen-plus-progestogen, systemic oestrogen alone, systemic progestogen alone and topical vaginal oestrogen^[1]
At the FDA's request, 29 drug companies have submitted proposed label changes, so more products will follow^[1]
The removal began with the HHS announcement of November 2025; the endometrial cancer warning on systemic oestrogen-alone products stays^[1][4]
The FDA says about 41 million US women were aged 45 to 64 in 2020, yet only about 2 million women aged 46 to 65 received a hormone-therapy prescription^[1]

@HealthDesk

参考资料 4可信度 84%

第一项始终是图钉的来源。总体可信度是各份资料对上方所用开始和结束时间支持程度的加权平均；资料每比最新的一份旧 180 天，权重减半。

[1]90%
fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products
fda.gov· 发布于 2026年9月25日· 开始 2026年2月12日 ✓· 占评分 47%
The FDA^[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".
[2]70%
FDA removes black box warning from hormone therapy (ABC News)
youtube.com· 发表于 2026年2月19日· 占评分 20%
Makary explains the decision to lift the warning and addresses safety and supply concerns.^[1]
[3]85%
FDA Approves Labeling Changes to Menopausal Hormone Therapy Products (The ASCO Post)
ascopost.com· 发表于 2026年2月12日· 占评分 20%
Reports the six approved label changes, one batch spanning all four HRT categories, with 29 companies having submitted changes.^[1]
[4]85%
HHS Advances Women's Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy
fda.gov· 发表于 2025年11月10日· 占评分 14%
The November 2025 announcement that began the process and kept the endometrial cancer warning for systemic oestrogen-alone products.^[1]

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健康2026/09/25@HealthDesk
HHS and FDA Move to Strip Boxed Warnings From Menopause Hormone Therapy
U.S. Food and Drug AdministrationU.S. Department of Health and Human Services, 200, Independence Avenue Southwest, Ward 6, Washington, District of Columbia, 20201, United States
开始于 2025/11/10 16:09已确认可信度 86%319天前The 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.
0.78
健康2026/09/25@HealthDesk
FDA Decision Due on Roche's Giredestrant for Early Breast Cancer
RocheMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
开始于 2026/11/30已排期可信度 78%66天后Roche's^[1] release says "The FDA is expected to make a decision on the approval by 30 November 2026", the PDUFA goal date set under Priority Review.
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.
0.72
健康2026/09/25@HealthDesk
FDA Approves Opill, the First US Birth Control Pill Without a Prescription
PerrigoMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
开始于 2023/07/13已确认可信度 90%3.2年前The FDA^[1] news release is headed "For Immediate Release: July 13, 2023" and says "Today, the U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use".
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.
0.70
健康2026/09/25@HealthDesk
FDA Approves Bayer's Lynkuet, a Dual NK1/NK3 Hot-Flash Pill
BayerMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
开始于 2025/10/24 17:25已确认可信度 87%336天前Bayer's^[1] release is stamped "24 October 2025 | 19:25 PM Europe/Amsterdam" and opens "Berlin, October 24, 2025 - Bayer announced today that the U.S. Food and Drug Administration (FDA^[2]) has approved elinzanetant".
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.
0.70
健康2026/09/25@HealthDesk
FDA Approves Veozah, the First Non-Hormonal NK3 Pill for Hot Flashes
Astellas PharmaMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
开始于 2023/05/12已确认可信度 90%3.4年前The FDA^[1][2][3] news release is headed "For Immediate Release: May 12, 2023" and says "Today, the U.S. Food and Drug Administration approved Veozah (fezolinetant)".
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.
0.69
健康2026/09/23@HealthDesk
礼来向 FDA 提交 retatrutide 上市申请
Eli LillyEli Lilly and Company Corporate Center, East McCarty Street, Indianapolis, Indiana 46206, United States
开始于 2027/03/31预估延期3个月可信度 77%187天后礼来“计划随后于 2027 年第一季度提交 retatrutide 的美国上市申请”——未给出具体日期，因此本条目取 2027 年第一季度的最后一天。^[1]
礼来计划在完成生产数据包后，于 2027 年第一季度向 FDA 提交 retatrutide 的生物制品许可申请；这款三重激素减重针剂在三期试验中最多使体重下降 28.3%。
0.67
健康2026/09/25@HealthDesk
FDA Approves Teal Wand, the First At-Home Cervical Cancer Screening Kit
Teal HealthMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
开始于 2025/05/09 14:33已确认可信度 85%1.4年前The release is datelined "SAN FRANCISCO, May 9, 2025", stamped 10:33 ET, and says Teal Health "today announced the Food and Drug Administration's (FDA) approval of the Teal Wand".^[1]
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.
0.67
健康2026/09/25@HealthDesk
FDA Rule Requiring Breast Density Notices With Every Mammogram Takes Effect
U.S. Food and Drug AdministrationMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
开始于 2024/09/10已确认可信度 89%2年前The FDA^[1] page says "Enforcement of the MQSA regulations as amended by the 2023 MQSA Final Rule began on September 10, 2024"; the rule has no end date, so the period is open-ended.
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.
0.67
法律2026/09/25@LawDesk
Supreme Court Rejects Challenge to Mifepristone in FDA v. Alliance
Supreme Court of the United StatesSupreme Court of the United States, 1, 1st Street Northeast, Ward 6, Washington, District of Columbia, 20543, United States
开始于 2024/06/13已确认可信度 84%2.3年前The slip opinion in No. 23-235 is headed "Argued March 26, 2024—Decided June 13, 2024".^[1]
A unanimous Supreme Court threw out anti-abortion doctors' challenge to the FDA's rules for the abortion pill mifepristone, holding they had no standing to sue, so mail and telehealth access stayed in place.
0.66
健康2026/09/23@HealthDesk
FDA 批准雅培 Libre Duo 血糖-酮体传感器
Abbott Laboratories1360 South Loop Road, Alameda, Alameda County, California, 94502, United States
开始于 2026/08/25已确认可信度 87%31天前新闻稿落款为“伊利诺伊州雅培园，2026 年 8 月 25 日”，称雅培“今天宣布其 Libre Duo 10 Day 系统获得美国食品药品监督管理局（FDA^[2][3]）批准”；FDA 的 De Novo 记录给出相同的决定日期 08/25/2026。
FDA 批准雅培的 Libre Duo 10 Day，这是首款同时连续监测血糖和酮体的可穿戴设备，可在发生糖尿病酮症酸中毒之前提醒 2 岁及以上的糖尿病患者酮体正在升高。
0.66
健康2026/09/25@HealthDesk
FDA Approves Zurzuvae, the First Pill for Postpartum Depression
Sage TherapeuticsMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
开始于 2023/08/04已确认可信度 89%3.1年前The FDA^[1] news release is headed "For Immediate Release: August 04, 2023" and says "Today, the U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression".
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.
0.66
健康2026/09/25@HealthDesk
FDA Puts a Boxed Liver-Injury Warning on Menopause Drug Veozah
Astellas PharmaMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
开始于 2024/12/16已确认可信度 87%1.8年前The 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.
0.65

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参考资料 4可信度 84%

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