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
开始于 2023/05/12已确认可信度 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.
0.72
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.
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
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.
0.71
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。
0.71
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.
0.69
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.
0.68
法律2026/09/25@LawDesk
Fifth Circuit Reinstates In-Person Dispensing for Mifepristone
United States Court of Appeals for the Fifth CircuitUnited States Court of Appeals Fifth Circuit, 600, Camp Street, Central Business District, French Quarter, New Orleans, Orleans Parish, Louisiana, 70130, United States
开始于 2026/05/01已确认可信度 82%147天前The 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.
0.67
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.
0.66
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。
0.65
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%。
0.65
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。
0.65
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.
0.64

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".

开始: 2023年8月4日可信度 90%来自来源

FDA Approves Zurzuvae, the First Pill for 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.

The FDA approved Zurzuvae (zuranolone) on 4 August 2023 as the first oral medicine for postpartum depression in adults^[1][3]
Until then PPD treatment was only an IV infusion given in certain health care facilities (Sage's Zulresso)^[1][4]
The FDA declined to approve it for major depressive disorder the same day^[3][4]
Sage and Biogen priced the two-week course at $15,900 in November 2023 and planned to start selling it that December, after DEA scheduling^[2]
The application had Priority Review and Fast Track designation^[1]

Notable features

50 mg once daily in the evening with a fatty meal, for 14 days^[1]
In two placebo-controlled trials, women improved significantly on the HAMD-17 depression scale at day 15, and the effect held at day 42^[1]
Boxed warning: patients should not drive or operate heavy machinery for at least 12 hours after a dose^[1]

@HealthDesk

参考资料 5可信度 89%

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-first-oral-treatment-postpartum-depression
fda.gov· 发布于 2026年9月25日· 开始 2023年8月4日 ✓· 占评分 95%
The FDA 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".
[2]80%
Biogen, Sage set price of postpartum depression pill at $15,900 (BioPharma Dive)
biopharmadive.com· 发表于 2023年11月7日· 占评分 2%
The two-week course was priced at $15,900, with sales planned from December 2023 once DEA scheduling was done; the MDD rejection sharply limited its market.^[1]
[3]85%
FDA approves Sage Therapeutics' rapid-acting medication for postpartum depression but not major depression (STAT)
statnews.com· 发表于 2023年8月4日· 占评分 1%
STAT: approved Friday as the first oral treatment for PPD, taken for 14 days; the application for major depression was denied.^[1]
[4]80%
Sage, Biogen Drug Is Now the First Approved Oral Med for Postpartum Depression (MedCity News)
medcitynews.com· 发表于 2023年8月4日· 占评分 1%
Zurzuvae is Sage's second PPD approval after the 2019 IV drug Zulresso; it did not win approval in major depressive disorder, a blow to the Sage-Biogen partnership.^[1]
[5]75%
FDA Approves Zuranolone, a Pill for Postpartum Depression Treatment (Policy Center for Maternal Mental Health)
policycentermmh.org· 发表于 2023年8月4日· 占评分 1%
Maternal mental health advocates on why an oral 14-day treatment an OB-GYN or midwife can prescribe matters.^[1]

建议更正

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1FDA Approves Zurzuvae, the First Pill for Postpartum Depression

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
开始于 2023/05/12已确认可信度 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.
0.72
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.
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
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.
0.71
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。
0.71
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.
0.69
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.
0.68
法律2026/09/25@LawDesk
Fifth Circuit Reinstates In-Person Dispensing for Mifepristone
United States Court of Appeals for the Fifth CircuitUnited States Court of Appeals Fifth Circuit, 600, Camp Street, Central Business District, French Quarter, New Orleans, Orleans Parish, Louisiana, 70130, United States
开始于 2026/05/01已确认可信度 82%147天前The 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.
0.67
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.
0.66
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。
0.65
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%。
0.65
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。
0.65
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.
0.64

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Notable features

参考资料 5可信度 89%

建议更正

评论

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