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.
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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)".

开始: 2023年5月12日可信度 90%来自来源

FDA Approves Veozah, the First Non-Hormonal NK3 Pill for Hot Flashes

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.

The FDA approved Veozah (fezolinetant) on 12 May 2023 for moderate to severe hot flashes caused by menopause^[1][2]
It is the first neurokinin 3 (NK3) receptor antagonist approved for menopausal hot flashes, and it is not a hormone, so it is an option for women who cannot take hormone therapy^[1]
Hot flashes affect around 80% of menopausal women, according to the FDA^[1]
The label carried a warning for elevated liver enzymes, requiring blood tests before treatment and every three months for the first nine months^[1]
The application had Priority Review, and the approval went to Astellas Pharma US^[1][5]

Notable features

One 45 mg tablet once a day, with or without food^[1]
Blocks the NK3 receptor, which plays a role in the brain's regulation of body temperature^[1][3]
Efficacy shown in the 12-week placebo-controlled parts of two phase 3 trials, each running 52 weeks in total, with an average participant age of 54^[1]
Not for use with CYP1A2 inhibitors or in people with cirrhosis or severe kidney disease^[1]

@HealthDesk

参考资料 5可信度 90%

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-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause
fda.gov· 发布于 2026年9月25日· 开始 2023年5月12日 ✓· 占评分 48%
The FDA^[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)".
[2]90%
Novel Drug Approvals for 2023 (FDA)
fda.gov· 添加于 2026年9月25日· 占评分 48%
FDA's^[1][3] 2023 list gives Veozah (fezolinetant) an approval date of 5/12/2023, to treat moderate to severe hot flashes caused by menopause.
[3]80%
FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant)
fda.gov· 发表于 2024年9月12日· 占评分 3%
Later FDA^[1][2] safety communication describing Veozah as a nonhormonal medicine approved in May 2023 that blocks the NK3 receptor in the brain's temperature control centre.
[4]70%
FDA approves Veozah, new drug to battle menopausal hot flashes (WKYC Channel 3)
youtube.com· 发表于 2023年5月16日· 占评分 0%
Local TV report on the approval with a patient whose hot flashes began at 50.^[1]
[5]90%
Astellas' VEOZAH (fezolinetant) Approved by U.S. FDA for Treatment of Vasomotor Symptoms Due to Menopause
newsroom.astellas.com· 发表于 2023年5月13日· 占评分 0%
Astellas' release: the FDA^[1][2][3] approved Veozah 45 mg once daily on May 12; it is the first nonhormonal NK3 receptor antagonist for VMS, backed by the BRIGHT SKY programme (SKYLIGHT 1, 2 and 4) of over 3,000 people.

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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.
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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.

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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.

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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.

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健康2026/09/20@TechDesk

礼来减重药 Foundayo（Orforglipron）获 FDA 批准

Eli LillyIndianapolis, Indiana

开始于 2026/04/01已确认可信度 85%177天前礼来和 FDA^[4] 批准函均显示批准日期为 2026 年 4 月 1 日。

FDA 批准礼来的 Foundayo，这是一款每日一次、服用时无需限制饮食或饮水的 GLP-1 减重口服药，自 4 月 6 日起开始面向消费者直销。

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健康2026/09/25@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

开始于 2026/02/12已确认可信度 84%225天前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".

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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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.

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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%。

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健康2026/09/23@HealthDesk

FDA 批准 Icotyde：首款治疗银屑病的口服 IL-23 受体药丸

Johnson & JohnsonSpring House, Lower Gwynedd Township, Montgomery County, Pennsylvania, 19477, United States

开始于 2026/03/17 20:12已确认可信度 88%192天前FDA^[4] 针对 NDA 220149 的批准函称该申请“获得批准，自本函日期起生效”，电子签名时间为“03/17/2026 04:12:23 PM”（美国东部时间，UTC 20:12）；强生于次日上午宣布：“宾夕法尼亚州斯普林豪斯（2026 年 3 月 18 日）——……今天宣布美国食品药品监督管理局（FDA）已批准 ICOTYDE”。

FDA 批准强生的 Icotyde（icotrokinra），这是一种每日一次的药丸，也是首款阻断 IL-23 受体的靶向口服多肽，用于治疗成人及 12 岁以上、体重至少 40 公斤儿童的中重度斑块状银屑病。

0.68

健康2026/09/20@HealthDesk

Enicepatide 肥胖或超重 3 期试验读出结果

RocheBasel, Canton of Basel-Stadt, Switzerland

开始于 2028/07/24预估可信度 50%1.8年后ClinicalTrials.gov^[1] 列出的预计主要完成日期为 2028-07-24；这是申办方的估计，如此规模的试验经常延期。

罗氏的 enicepatide 肥胖或超重 3 期试验达到主要完成日期，即最后一名受试者的主要终点完成测量之时。该试验入组 2,000 名受试者。本研究旨在评估胰高血糖素样肽-1（GLP-1）/葡萄糖依赖性促胰岛素多肽（GIP）受体双重激动剂（RA）enicepatide 多个剂量与安慰剂相比，在不伴 2 型糖尿病（T2DM）、患有肥胖或超重且伴有至少一种体重相关合并症的受试者中用于体重管理的有效性和安全性。

0.68

健康2026/09/25@HealthDesk

FDA Approves Evita Solutions' Generic Mifepristone

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

开始于 2025/09/30 14:20已确认可信度 83%360天前The 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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健康2026/09/23@HealthDesk

FDA批准礼来Inluriyo联合Verzenio用于ESR1突变乳腺癌

Eli LillyBowditch Road, Federal Research Center, Hillandale, Montgomery County, Maryland, 20993, United States

开始于 2026/09/18已确认可信度 85%7天前礼来的新闻稿标注发稿地与日期为“印第安纳波利斯，2026年9月18日”，并称公司“今日宣布美国食品药品监督管理局（FDA^[4]）已给予完全批准”；FDA自身的公告也将批准日期列为2026年9月18日。

这一全口服组合在EMBER-3试验中将ESR1突变患者的中位无进展生存期从5.5个月翻倍至11.1个月。这是Inluriyo不到一年内获得的第二项FDA批准。

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参考资料 5可信度 90%

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