Salud25/09/2026@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
Empieza el 10/11/2025 16:09CONFIRMADO 86% DE CONFIANZAhace 319 díasThe 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
Salud25/09/2026@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
Empieza el 30/11/2026PROGRAMADO 78% DE CONFIANZAdentro de 66 díasRoche'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
Salud25/09/2026@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
Empieza el 13/07/2023CONFIRMADO 90% DE CONFIANZAhace 3,2 añosThe 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
Salud25/09/2026@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
Empieza el 24/10/2025 17:25CONFIRMADO 87% DE CONFIANZAhace 336 díasBayer'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
Salud25/09/2026@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
Empieza el 12/05/2023CONFIRMADO 90% DE CONFIANZAhace 3,4 añosThe 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.
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Salud23/09/2026@HealthDesk
Lilly presenta la retatrutida a la FDA para su aprobación
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Lilly prevé presentar ante la FDA su solicitud de licencia de producto biológico para la retatrutida, la inyección triple hormonal contra la obesidad que redujo el peso hasta un 28,3% en fase 3, en el primer trimestre de 2027, una vez completado su paquete de datos de fabricación.
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Salud25/09/2026@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
Empieza el 09/05/2025 14:33CONFIRMADO 85% DE CONFIANZAhace 1,4 añosThe 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]
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Salud25/09/2026@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
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0.67
Derecho25/09/2026@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
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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.
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Salud23/09/2026@HealthDesk
La FDA autoriza el sensor de glucosa y cetonas Libre Duo de Abbott
Abbott Laboratories1360 South Loop Road, Alameda, Alameda County, California, 94502, United States
Empieza el 25/08/2026CONFIRMADO 87% DE CONFIANZAhace 31 díasEl comunicado está fechado en «ABBOTT PARK, Ill., 25 de agosto de 2026» y dice que Abbott «ha anunciado hoy la autorización de la Administración de Alimentos y Medicamentos de EE. UU. (FDA^[2][3]) para su sistema Libre Duo 10 Day»; el registro De Novo de la FDA indica la misma fecha de decisión, el 25/08/2026.
La FDA autorizó el Libre Duo 10 Day de Abbott, el primer dispositivo ponible que controla de forma continua tanto la glucosa como las cetonas, y que avisa a las personas con diabetes de 2 años o más de la subida de las cetonas antes de una cetoacidosis diabética.
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Salud25/09/2026@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
Empieza el 04/08/2023CONFIRMADO 89% DE CONFIANZAhace 3,1 añosThe 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
Salud25/09/2026@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
Empieza el 16/12/2024CONFIRMADO 87% DE CONFIANZAhace 1,8 añosThe 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".

Inicio: 12 feb 202690% DE CONFIANZAsegún la fuente

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

Referencias 484% DE CONFIANZA

La primera entrada es siempre la fuente del pin. La confianza global es una media ponderada de la firmeza con la que cada referencia respalda las horas de inicio y fin usadas arriba; una referencia cuenta la mitad por cada 180 días que sea más antigua que la más reciente.

[1]90%
fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products
fda.gov· Publicado el 25 sept 2026· Empieza 12 feb 2026 ✓· 47% de la puntuación
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· Publicado el 19 feb 2026· 20% de la puntuación
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· Publicado el 12 feb 2026· 20% de la puntuación
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· Publicado el 10 nov 2025· 14% de la puntuación
The November 2025 announcement that began the process and kept the endometrial cancer warning for systemic oestrogen-alone products.^[1]

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Salud25/09/2026@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
Empieza el 10/11/2025 16:09CONFIRMADO 86% DE CONFIANZAhace 319 díasThe 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
Salud25/09/2026@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
Empieza el 30/11/2026PROGRAMADO 78% DE CONFIANZAdentro de 66 díasRoche'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
Salud25/09/2026@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
Empieza el 13/07/2023CONFIRMADO 90% DE CONFIANZAhace 3,2 añosThe 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
Salud25/09/2026@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
Empieza el 24/10/2025 17:25CONFIRMADO 87% DE CONFIANZAhace 336 díasBayer'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
Salud25/09/2026@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
Empieza el 12/05/2023CONFIRMADO 90% DE CONFIANZAhace 3,4 añosThe 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
Salud23/09/2026@HealthDesk
Lilly presenta la retatrutida a la FDA para su aprobación
Eli LillyEli Lilly and Company Corporate Center, East McCarty Street, Indianapolis, Indiana 46206, United States
Empieza el 31/03/2027ESTIMADO3 meses de retraso77% DE CONFIANZAdentro de 187 díasLilly «prevé presentar después la retatrutida en el primer trimestre de 2027 para su aprobación en EE. UU.»; no se indica día, así que el pin toma el último día del primer trimestre de 2027.^[1]
Lilly prevé presentar ante la FDA su solicitud de licencia de producto biológico para la retatrutida, la inyección triple hormonal contra la obesidad que redujo el peso hasta un 28,3% en fase 3, en el primer trimestre de 2027, una vez completado su paquete de datos de fabricación.
0.67
Salud25/09/2026@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
Empieza el 09/05/2025 14:33CONFIRMADO 85% DE CONFIANZAhace 1,4 añosThe 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
Salud25/09/2026@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
Empieza el 10/09/2024CONFIRMADO 89% DE CONFIANZAhace 2 añosThe 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
Derecho25/09/2026@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
Empieza el 13/06/2024CONFIRMADO 84% DE CONFIANZAhace 2,3 añosThe 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
Salud23/09/2026@HealthDesk
La FDA autoriza el sensor de glucosa y cetonas Libre Duo de Abbott
Abbott Laboratories1360 South Loop Road, Alameda, Alameda County, California, 94502, United States
Empieza el 25/08/2026CONFIRMADO 87% DE CONFIANZAhace 31 díasEl comunicado está fechado en «ABBOTT PARK, Ill., 25 de agosto de 2026» y dice que Abbott «ha anunciado hoy la autorización de la Administración de Alimentos y Medicamentos de EE. UU. (FDA^[2][3]) para su sistema Libre Duo 10 Day»; el registro De Novo de la FDA indica la misma fecha de decisión, el 25/08/2026.
La FDA autorizó el Libre Duo 10 Day de Abbott, el primer dispositivo ponible que controla de forma continua tanto la glucosa como las cetonas, y que avisa a las personas con diabetes de 2 años o más de la subida de las cetonas antes de una cetoacidosis diabética.
0.66
Salud25/09/2026@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
Empieza el 04/08/2023CONFIRMADO 89% DE CONFIANZAhace 3,1 añosThe 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
Salud25/09/2026@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
Empieza el 16/12/2024CONFIRMADO 87% DE CONFIANZAhace 1,8 añosThe 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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