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
開始 2025/11/10 16:09確定確度 86%319 日前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
開始 2026/11/30予定確度 78%66 日後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
開始 2023/07/13確定確度 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
開始 2025/10/24 17:25確定確度 87%336 日前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
開始 2023/05/12確定確度 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
リリー、レタトルチドの承認をFDAに申請
Eli LillyEli Lilly and Company Corporate Center, East McCarty Street, Indianapolis, Indiana 46206, United States
開始 2027/03/31推定3 か月遅れ確度 77%187 日後リリーは「その後、2027年第1四半期にレタトルチドの米国での承認を申請する計画だ」としている。日付は示されていないため、ピンは2027年第1四半期の最終日とした。^[1]
リリーは、第3相試験で最大28.3%の体重減少を示した3種のホルモンに作用する肥満症注射薬レタトルチドについて、製造関連データのパッケージが整い次第、2027年第1四半期に米食品医薬品局（FDA）に生物製剤承認申請（BLA）を行う計画である。
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
開始 2025/05/09 14:33確定確度 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
開始 2024/09/10確定確度 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
開始 2024/06/13確定確度 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、アボットの血糖・ケトン同時測定センサー「Libre Duo」を認可
Abbott Laboratories1360 South Loop Road, Alameda, Alameda County, California, 94502, United States
開始 2026/08/25確定確度 87%31 日前発表資料は「イリノイ州アボットパーク、2026年8月25日」付で、アボットが「本日、Libre Duo 10 Dayシステムの米食品医薬品局（FDA^[2][3]）による認可を発表した」としている。FDAのDe Novoの記録でも決定日は同じ2026年8月25日である。
米食品医薬品局（FDA）は、血糖とケトンの両方を継続的に測定する初のウェアラブル機器であるアボットのLibre Duo 10 Dayを認可した。2歳以上の糖尿病患者に、糖尿病性ケトアシドーシスに至る前にケトンの上昇を知らせる。
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
開始 2023/08/04確定確度 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
開始 2024/12/16確定確度 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".

開始: 2026年2月12日確度 90%出典：出典

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

参考資料 4確度 84%

最初の項目は常にピンの出典です。全体の確度は、各資料が上記の開始・終了時刻をどれだけ強く裏付けているかの加重平均です。最新の資料より180日古くなるごとに、重みは半分になります。

[1]90%
fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products
fda.gov· 投稿 2026年9月25日· 開始 2026年2月12日 ✓· スコアの 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· 公開 2026年2月19日· スコアの 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· 公開 2026年2月12日· スコアの 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· 公開 2025年11月10日· スコアの 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
開始 2025/11/10 16:09確定確度 86%319 日前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
開始 2026/11/30予定確度 78%66 日後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
開始 2023/07/13確定確度 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
開始 2025/10/24 17:25確定確度 87%336 日前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
開始 2023/05/12確定確度 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
リリー、レタトルチドの承認をFDAに申請
Eli LillyEli Lilly and Company Corporate Center, East McCarty Street, Indianapolis, Indiana 46206, United States
開始 2027/03/31推定3 か月遅れ確度 77%187 日後リリーは「その後、2027年第1四半期にレタトルチドの米国での承認を申請する計画だ」としている。日付は示されていないため、ピンは2027年第1四半期の最終日とした。^[1]
リリーは、第3相試験で最大28.3%の体重減少を示した3種のホルモンに作用する肥満症注射薬レタトルチドについて、製造関連データのパッケージが整い次第、2027年第1四半期に米食品医薬品局（FDA）に生物製剤承認申請（BLA）を行う計画である。
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
開始 2025/05/09 14:33確定確度 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
開始 2024/09/10確定確度 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
開始 2024/06/13確定確度 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、アボットの血糖・ケトン同時測定センサー「Libre Duo」を認可
Abbott Laboratories1360 South Loop Road, Alameda, Alameda County, California, 94502, United States
開始 2026/08/25確定確度 87%31 日前発表資料は「イリノイ州アボットパーク、2026年8月25日」付で、アボットが「本日、Libre Duo 10 Dayシステムの米食品医薬品局（FDA^[2][3]）による認可を発表した」としている。FDAのDe Novoの記録でも決定日は同じ2026年8月25日である。
米食品医薬品局（FDA）は、血糖とケトンの両方を継続的に測定する初のウェアラブル機器であるアボットのLibre Duo 10 Dayを認可した。2歳以上の糖尿病患者に、糖尿病性ケトアシドーシスに至る前にケトンの上昇を知らせる。
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
開始 2023/08/04確定確度 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
開始 2024/12/16確定確度 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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