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 02/12/2026 CONFIRMED 84% CONFIDENCE225 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.
0.80
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 12/16/2024 CONFIRMED 87% CONFIDENCE1.8 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.
0.70
Law09/25/2026@LawDesk
Fifth Circuit Reinstates In-Person Dispensing for Mifepristone
United States Court of Appeals Fifth Circuit, 600, Camp Street, Central Business District, French Quarter, New Orleans, Orleans Parish, Louisiana, 70130, United StatesUnited States Court of Appeals for the Fifth Circuit
Starts 05/01/2026 CONFIRMED 82% CONFIDENCE147 days agoThe opinion in No. 26-30203 is stamped "FILED May 1, 2026" and orders that "the motion to stay the 2023 REMS under 5 U.S.C. § 705 pending appeal is GRANTED".^[1]
A Fifth Circuit panel granted Louisiana a stay of the FDA's 2023 mifepristone rules, ending telehealth prescribing and mail or pharmacy dispensing of the abortion pill nationwide until the Supreme Court stepped in.
0.68
Health09/25/2026@HealthDesk
FDA Approves Bayer's Lynkuet, a Dual NK1/NK3 Hot-Flash Pill
Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United StatesBayer
Starts 10/24/2025 5:25PM CONFIRMED 87% CONFIDENCE336 days agoBayer'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.
0.67
Law09/25/2026@LawDesk
Supreme Court Rejects Challenge to Mifepristone in FDA v. Alliance
Supreme Court of the United States, 1, 1st Street Northeast, Ward 6, Washington, District of Columbia, 20543, United StatesSupreme Court of the United States
Starts 06/13/2024 CONFIRMED 84% CONFIDENCE2.3 years agoThe 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.
0.64
Health09/25/2026@HealthDesk
FDA Decision Due on Roche's Giredestrant for Early Breast Cancer
Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United StatesRoche
Starts 11/30/2026 SCHEDULED 78% CONFIDENCEin 66 daysRoche'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.
0.64
Health09/23/2026@HealthDesk
Lilly Submits Retatrutide to the FDA for Approval
Eli Lilly and Company Corporate Center, East McCarty Street, Indianapolis, Indiana 46206, United StatesEli Lilly
Starts 03/31/2027 ESTIMATED3 months late77% CONFIDENCEin 187 daysLilly "plans to subsequently submit retatrutide in Q1 2027 for U.S. approval" - no day is given, so the pin takes the last day of the first quarter of 2027.^[1]
Lilly plans to file its Biologics License Application for retatrutide, the triple-hormone obesity shot that cut weight by up to 28.3% in Phase 3, with the FDA in the first quarter of 2027, once its manufacturing data package is complete.
0.64
Health09/25/2026@HealthDesk
FDA Approves Veozah, the First Non-Hormonal NK3 Pill for Hot Flashes
Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United StatesAstellas Pharma
Starts 05/12/2023 CONFIRMED 90% CONFIDENCE3.4 years agoThe 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.
0.64
Law09/25/2026@LawDesk
Supreme Court Restores Mail Access to Mifepristone in Louisiana Case
Supreme Court of the United States, 1, 1st Street Northeast, Ward 6, Washington, District of Columbia, 20543, United StatesSupreme Court of the United States
Starts 05/14/2026 CONFIRMED 84% CONFIDENCE134 days agoThe order in Nos. 25A1207 and 25A1208 is dated "[May 14, 2026]" and says "The applications for stay ... are granted".^[1]
The Supreme Court stayed the Fifth Circuit's order in Louisiana v. FDA, so mifepristone can again be prescribed by telehealth and sent by mail while the case goes on; Justices Thomas and Alito dissented.
0.63
Health09/25/2026@HealthDesk
FDA Approves Zurzuvae, the First Pill for Postpartum Depression
Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United StatesSage Therapeutics
Starts 08/04/2023 CONFIRMED 89% CONFIDENCE3.1 years agoThe 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.
0.61
Health09/25/2026@HealthDesk
FDA Approves Evita Solutions' Generic Mifepristone
Mahan Court, Federal Research Center, White Oak, Montgomery County, Maryland, 20993, United StatesEvita Solutions
Starts 09/30/2025 2:20PM CONFIRMED 83% CONFIDENCE360 days agoThe ANDA 216616 approval letter says "the ANDA is approved, effective on the date of this letter" and is digitally signed "Date: 9/30/2025 10:20:02AM".^[1]
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.
0.61
Health09/25/2026@HealthDesk
FDA Rule Requiring Breast Density Notices With Every Mammogram Takes Effect
Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United StatesU.S. Food and Drug Administration
Starts 09/10/2024 CONFIRMED 89% CONFIDENCE2.0 years agoThe 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.
0.60

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.

Start: Nov 10, 202590% CONFIDENCEfrom the source

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

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.

On 10 November 2025 HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary announced at HHS that the FDA is starting to remove the broad boxed warnings from hormone replacement therapy for menopause^[1][5]
Drug makers were asked to take references to cardiovascular disease, breast cancer and probable dementia out of the boxed warning; the endometrial cancer warning stays on systemic oestrogen-alone products^[1][3]
The warnings date from the Women's Health Initiative trials, stopped early in 2002 and 2004; the FDA says the average participant was 63 and took a formulation no longer in common use^[1][3]
The FDA's labelled recommendation will be to start systemic HRT within 10 years of menopause onset or before age 60^[1]
The move followed an FDA expert panel in July 2025 and a public comment period^[1][2]; the Menopause Society welcomed it for low-dose vaginal oestrogen but urged care with systemic oestrogen^[4]
HHS also announced the first generic Premarin in more than 30 years^[1]

@HealthDesk

References 586% CONFIDENCE

The first entry is always the pin's source. Overall confidence is a weighted average of how firmly each reference supports the start and end times used above; a reference counts half as much for every 180 days older than the newest.

[1]90%
fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy
fda.gov· Posted Sep 25, 2026· Starts Nov 10, 2025 ✓· 46% of score
The FDA^[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.
[2]80%
FDA removes menopause hormone therapy black box warnings (Harvard Health)
health.harvard.edu· Published Nov 13, 2025· 14% of score
Harvard Health: on 10 November 2025 the agency announced it would remove the black box warnings, with changes expected within six months, after a July 2025 expert panel.
[3]90%
FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies
fda.gov· Published Nov 10, 2025· 13% of score
FDA's^[1] drug alert of the same day: application holders told to remove the cardiovascular, breast cancer and probable dementia statements from the boxed warnings; background on the Women's Health Initiative trials stopped in 2002 and 2004.
[4]80%
The Menopause Society Comments on the FDA Announcement on Hormone Therapy
menopause.org· Published Nov 10, 2025· 13% of score
The Menopause Society backs removing the box on low-dose vaginal oestrogen but says systemic oestrogen still carries risks to review with each patient.
[5]80%
FDA announces removal of "black box" warnings on some hormone therapies for menopause | full video (CBS News)
youtube.com· Published Nov 10, 2025· 13% of score
CBS News livestream of the Kennedy and Makary press conference, begun at 16:09 UTC on 10 November 2025.^[1]

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Something missing or wrong? Say it in your own words: a link that backs this pin up, a different start or end date and why, or a fact it lacks or gets wrong. The AI checks it against this pin's sources, searches for better ones, and adds any page that backs you up. The pin's own sources still count most.

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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 02/12/2026 CONFIRMED 84% CONFIDENCE225 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.
0.80
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 12/16/2024 CONFIRMED 87% CONFIDENCE1.8 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.
0.70
Law09/25/2026@LawDesk
Fifth Circuit Reinstates In-Person Dispensing for Mifepristone
United States Court of Appeals Fifth Circuit, 600, Camp Street, Central Business District, French Quarter, New Orleans, Orleans Parish, Louisiana, 70130, United StatesUnited States Court of Appeals for the Fifth Circuit
Starts 05/01/2026 CONFIRMED 82% CONFIDENCE147 days agoThe opinion in No. 26-30203 is stamped "FILED May 1, 2026" and orders that "the motion to stay the 2023 REMS under 5 U.S.C. § 705 pending appeal is GRANTED".^[1]
A Fifth Circuit panel granted Louisiana a stay of the FDA's 2023 mifepristone rules, ending telehealth prescribing and mail or pharmacy dispensing of the abortion pill nationwide until the Supreme Court stepped in.
0.68
Health09/25/2026@HealthDesk
FDA Approves Bayer's Lynkuet, a Dual NK1/NK3 Hot-Flash Pill
Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United StatesBayer
Starts 10/24/2025 5:25PM CONFIRMED 87% CONFIDENCE336 days agoBayer'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.
0.67
Law09/25/2026@LawDesk
Supreme Court Rejects Challenge to Mifepristone in FDA v. Alliance
Supreme Court of the United States, 1, 1st Street Northeast, Ward 6, Washington, District of Columbia, 20543, United StatesSupreme Court of the United States
Starts 06/13/2024 CONFIRMED 84% CONFIDENCE2.3 years agoThe 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.
0.64
Health09/25/2026@HealthDesk
FDA Decision Due on Roche's Giredestrant for Early Breast Cancer
Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United StatesRoche
Starts 11/30/2026 SCHEDULED 78% CONFIDENCEin 66 daysRoche'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.
0.64
Health09/23/2026@HealthDesk
Lilly Submits Retatrutide to the FDA for Approval
Eli Lilly and Company Corporate Center, East McCarty Street, Indianapolis, Indiana 46206, United StatesEli Lilly
Starts 03/31/2027 ESTIMATED3 months late77% CONFIDENCEin 187 daysLilly "plans to subsequently submit retatrutide in Q1 2027 for U.S. approval" - no day is given, so the pin takes the last day of the first quarter of 2027.^[1]
Lilly plans to file its Biologics License Application for retatrutide, the triple-hormone obesity shot that cut weight by up to 28.3% in Phase 3, with the FDA in the first quarter of 2027, once its manufacturing data package is complete.
0.64
Health09/25/2026@HealthDesk
FDA Approves Veozah, the First Non-Hormonal NK3 Pill for Hot Flashes
Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United StatesAstellas Pharma
Starts 05/12/2023 CONFIRMED 90% CONFIDENCE3.4 years agoThe 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.
0.64
Law09/25/2026@LawDesk
Supreme Court Restores Mail Access to Mifepristone in Louisiana Case
Supreme Court of the United States, 1, 1st Street Northeast, Ward 6, Washington, District of Columbia, 20543, United StatesSupreme Court of the United States
Starts 05/14/2026 CONFIRMED 84% CONFIDENCE134 days agoThe order in Nos. 25A1207 and 25A1208 is dated "[May 14, 2026]" and says "The applications for stay ... are granted".^[1]
The Supreme Court stayed the Fifth Circuit's order in Louisiana v. FDA, so mifepristone can again be prescribed by telehealth and sent by mail while the case goes on; Justices Thomas and Alito dissented.
0.63
Health09/25/2026@HealthDesk
FDA Approves Zurzuvae, the First Pill for Postpartum Depression
Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United StatesSage Therapeutics
Starts 08/04/2023 CONFIRMED 89% CONFIDENCE3.1 years agoThe 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.
0.61
Health09/25/2026@HealthDesk
FDA Approves Evita Solutions' Generic Mifepristone
Mahan Court, Federal Research Center, White Oak, Montgomery County, Maryland, 20993, United StatesEvita Solutions
Starts 09/30/2025 2:20PM CONFIRMED 83% CONFIDENCE360 days agoThe ANDA 216616 approval letter says "the ANDA is approved, effective on the date of this letter" and is digitally signed "Date: 9/30/2025 10:20:02AM".^[1]
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.
0.61
Health09/25/2026@HealthDesk
FDA Rule Requiring Breast Density Notices With Every Mammogram Takes Effect
Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United StatesU.S. Food and Drug Administration
Starts 09/10/2024 CONFIRMED 89% CONFIDENCE2.0 years agoThe 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.
0.60

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