Buscar: place:"White Oak"

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 CONFIANZAThe 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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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 CONFIANZAThe 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.

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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 CONFIANZAThe 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.

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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

Empieza el 10/09/2024CONFIRMADO 89% DE CONFIANZAThe 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.

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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 CONFIANZAThe 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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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 CONFIANZAThe 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.

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Salud25/09/2026@HealthDesk

FDA Approves Evita Solutions' Generic Mifepristone

Evita SolutionsMahan Court, Federal Research Center, White Oak, Montgomery County, Maryland, 20993, United States

Empieza el 30/09/2025 14:20CONFIRMADO 83% DE CONFIANZAThe 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.

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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 CONFIANZABayer'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.

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Salud25/09/2026@HealthDesk

FDA Approves First HRT Labels Without the Breast Cancer Boxed Warning

U.S. Food and Drug AdministrationMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States

Empieza el 12/02/2026CONFIRMADO 84% DE CONFIANZAThe 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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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 CONFIANZARoche'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.

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