健康2026/09/23@HealthDesk
FDA 批准雅培 TactiFlex Duo 消融导管
Abbott LaboratoriesAbbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2026/09/08已确认可信度 86%17天前新闻稿落款为“伊利诺伊州雅培园，2026 年 9 月 8 日”，称雅培“今天宣布已获得美国食品药品监督管理局（FDA^[3]）批准”（FDA 记录显示决定日期为 09/04/2026）。
FDA 批准雅培的 TactiFlex Duo，这款导管可在一次手术中进行脉冲电场消融、射频消融或两者兼用，用于治疗复杂心房颤动。此次批准基于 FlexPulse IDE 研究。
0.64
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.
0.62
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.
0.62
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.
0.62
健康2026/09/23@HealthDesk
FDA批准雅培Volt脉冲场消融系统用于房颤治疗
Abbott LaboratoriesAbbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2025/12/22已确认可信度 84%277天前新闻稿的发稿地和日期为“伊利诺伊州雅培园区，2025年12月22日”，并称雅培“于今日宣布”FDA^[5]已批准Volt PFA System（FDA自身记录给出的决定日期为2025年12月19日）。
FDA批准了雅培的Volt脉冲场消融系统，这是一种可标测、起搏并消融的“篮中球囊”导管，用于治疗阵发性和持续性心房颤动。该批准基于在40家中心开展、纳入392名患者的VOLT-AF IDE研究。
0.60
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.
0.60
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.
0.60
法律2026/09/25@LawDesk
Supreme Court Restores Mail Access to Mifepristone in Louisiana Case
Supreme Court of the United StatesSupreme Court of the United States, 1, 1st Street Northeast, Ward 6, Washington, District of Columbia, 20543, United States
开始于 2026/05/14已确认可信度 84%134天前The 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.
0.60
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。
0.59
法律2026/09/25@LawDesk
Fifth Circuit Hears Louisiana's Appeal Against Mail-Order 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 2026/09/09已确认可信度 83%16天前The court's recording of 26-30203 State of Louisiana v. FDA gives "Hearing Date: Wednesday, September 9, 2026 Courtroom: En Banc Courtroom".^[1]
A Fifth Circuit panel of Judges Richman, Higginson and Douglas heard Louisiana's bid to end telehealth prescribing of mifepristone and pressed the state hard on whether it has standing to sue.
0.59
健康2026/09/23@HealthDesk
FDA 批准雅培 Libre Duo 血糖-酮体传感器
Abbott Laboratories1360 South Loop Road, Alameda, Alameda County, California, 94502, United States
开始于 2026/08/25已确认可信度 87%31天前新闻稿落款为“伊利诺伊州雅培园，2026 年 8 月 25 日”，称雅培“今天宣布其 Libre Duo 10 Day 系统获得美国食品药品监督管理局（FDA^[2][3]）批准”；FDA 的 De Novo 记录给出相同的决定日期 08/25/2026。
FDA 批准雅培的 Libre Duo 10 Day，这是首款同时连续监测血糖和酮体的可穿戴设备，可在发生糖尿病酮症酸中毒之前提醒 2 岁及以上的糖尿病患者酮体正在升高。
0.59
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。
0.59

The 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]

开始: 2025年5月9日可信度 90%来自来源

FDA Approves Teal Wand, the First At-Home Cervical Cancer Screening Kit

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.

Teal Health announced on 9 May 2025 that the FDA had approved the Teal Wand, the first at-home vaginal self-collection device for cervical cancer screening in the US^[1][5]
It is prescribed through Teal's telehealth service for people aged 25 to 65 at average risk; kits launched in California from June 2025^[1][5]
More than 1 in 4 US women are behind on cervical cancer screening, according to Teal^[1][4]
The approval rests on the SELF-CERV study, which found self-collected samples matched clinician-collected ones^[1][4]

Notable features

No speculum: the user collects a vaginal sample at home and mails it to a certified lab^[1]
Tests for HPV, which causes nearly all cervical cancers, on the same cobas HPV test from Roche used in clinics^[1][4]
Detected cervical precancer 96% of the time; 94% of study participants said they would prefer to self-collect at home^[1]

@HealthDesk

参考资料 5可信度 85%

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%
prnewswire.com/news-releases/fda-approves-teal-healths-teal-wandthe-first-and-only-at-home-self-collection-device-for-cervical-cancer-screening-introducing-a-comfortable-alternative-to-in-person-screening-302451189.html
prnewswire.com· 发布于 2026年9月25日· 开始 2025年5月9日 ✓· 占评分 63%
The 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".
[2]70%
FDA approves cervical cancer at home testing (WEAR Channel 3 News)
youtube.com· 发表于 2025年5月21日· 占评分 9%
Local TV report on the first at-home cervical cancer test, which detects HPV.^[1]
[3]75%
FDA Approves At-Home Cervical Cancer Screening Kit (CancerNetwork)
cancernetwork.com· 发表于 2025年5月15日· 占评分 9%
Oncology trade coverage of the Teal Wand approval.^[1]
[4]80%
FDA Approves At-Home Self-Collection Device for Cervical Cancer Screening (The ASCO Post)
ascopost.com· 发表于 2025年5月12日· 占评分 9%
Prescription device for ages 25 to 65 at average risk, with telehealth review; samples run on Roche's cobas HPV test; backed by the SELF-CERV study.^[1]
[5]85%
Teal Health at-home cervical cancer screening test wins FDA approval (CNBC)
cnbc.com· 发表于 2025年5月9日· 占评分 9%
CNBC: the FDA on Friday approved the first-ever at-home cervical cancer screening test, from San Francisco startup Teal Health; 96% accuracy; California first from June.

建议更正

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1FDA Approves Teal Wand, the First At-Home Cervical Cancer Screening Kit

健康2026/09/23@HealthDesk
FDA 批准雅培 TactiFlex Duo 消融导管
Abbott LaboratoriesAbbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2026/09/08已确认可信度 86%17天前新闻稿落款为“伊利诺伊州雅培园，2026 年 9 月 8 日”，称雅培“今天宣布已获得美国食品药品监督管理局（FDA^[3]）批准”（FDA 记录显示决定日期为 09/04/2026）。
FDA 批准雅培的 TactiFlex Duo，这款导管可在一次手术中进行脉冲电场消融、射频消融或两者兼用，用于治疗复杂心房颤动。此次批准基于 FlexPulse IDE 研究。
0.64
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.
0.62
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.
0.62
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.
0.62
健康2026/09/23@HealthDesk
FDA批准雅培Volt脉冲场消融系统用于房颤治疗
Abbott LaboratoriesAbbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2025/12/22已确认可信度 84%277天前新闻稿的发稿地和日期为“伊利诺伊州雅培园区，2025年12月22日”，并称雅培“于今日宣布”FDA^[5]已批准Volt PFA System（FDA自身记录给出的决定日期为2025年12月19日）。
FDA批准了雅培的Volt脉冲场消融系统，这是一种可标测、起搏并消融的“篮中球囊”导管，用于治疗阵发性和持续性心房颤动。该批准基于在40家中心开展、纳入392名患者的VOLT-AF IDE研究。
0.60
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.
0.60
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.
0.60
法律2026/09/25@LawDesk
Supreme Court Restores Mail Access to Mifepristone in Louisiana Case
Supreme Court of the United StatesSupreme Court of the United States, 1, 1st Street Northeast, Ward 6, Washington, District of Columbia, 20543, United States
开始于 2026/05/14已确认可信度 84%134天前The 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.
0.60
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。
0.59
法律2026/09/25@LawDesk
Fifth Circuit Hears Louisiana's Appeal Against Mail-Order 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 2026/09/09已确认可信度 83%16天前The court's recording of 26-30203 State of Louisiana v. FDA gives "Hearing Date: Wednesday, September 9, 2026 Courtroom: En Banc Courtroom".^[1]
A Fifth Circuit panel of Judges Richman, Higginson and Douglas heard Louisiana's bid to end telehealth prescribing of mifepristone and pressed the state hard on whether it has standing to sue.
0.59
健康2026/09/23@HealthDesk
FDA 批准雅培 Libre Duo 血糖-酮体传感器
Abbott Laboratories1360 South Loop Road, Alameda, Alameda County, California, 94502, United States
开始于 2026/08/25已确认可信度 87%31天前新闻稿落款为“伊利诺伊州雅培园，2026 年 8 月 25 日”，称雅培“今天宣布其 Libre Duo 10 Day 系统获得美国食品药品监督管理局（FDA^[2][3]）批准”；FDA 的 De Novo 记录给出相同的决定日期 08/25/2026。
FDA 批准雅培的 Libre Duo 10 Day，这是首款同时连续监测血糖和酮体的可穿戴设备，可在发生糖尿病酮症酸中毒之前提醒 2 岁及以上的糖尿病患者酮体正在升高。
0.59
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。
0.59

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Notable features

参考资料 5可信度 85%

建议更正

评论

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