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.
0.73
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.
0.71
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.
0.68
法律2026/09/25@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
开始于 2024/06/13已确认可信度 84%2.3年前The 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.
0.67
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.
0.67
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%。
0.67
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.
0.67
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.
0.66
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。
0.66
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。
0.65
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。
0.65
健康2026/09/23@HealthDesk
礼来在米兰 EASD 2026 年会上公布 eloraTZP 二期结果
Allianz MiCo, Via Demetrio Stratos, Bolla, Milan, Lombardy 20149, ItalyEli Lilly
开始于 2026/09/30 14:30已排期可信度 86%5天后礼来的新闻稿列出“EloraTZP 专题研讨会 | 2026 年 9 月 30 日，星期三 | 欧洲中部夏令时间下午 4:30 至 5:30”，EASD^[2] 2026 最终日程也将该场次安排在 9 月 30 日（星期三）16:30 - 17:30，地点为布达佩斯厅。
礼来每周一次的胰淀素类药物 eloralintide 与替尔泊肽（Mounjaro、Zepbound）联用的 eloraTZP，首次公布在患有肥胖或超重且合并 2 型糖尿病的成人中的二期结果，于米兰 EASD 胰淀素专题研讨会上亮相。
0.65

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]

开始: 2025年9月30日可信度 90%来自来源

FDA Approves Evita Solutions' Generic Mifepristone

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.

The FDA approved Evita Solutions' abbreviated new drug application 216616 for mifepristone tablets, 200 mg, finding them bioequivalent and therapeutically equivalent to Danco's Mifeprex^[1]
Evita's product joins the single shared Mifepristone REMS Program, the safety programme covering mifepristone with misoprostol through 70 days' gestation^[1]
The application had been under review since 1 October 2021^[1]
It is the second generic after GenBioPro's in 2019; the FDA issued no press release, and Evita said the product would be available in January 2026^[4]
The approval came less than two weeks after HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary told Republican attorneys general the agency would review the drug's safety, and anti-abortion groups condemned it^[3][4]
That review, covering the 2023 rules that allow mail dispensing, is the one Louisiana's lawsuit later leaned on^[2]

Notable features

Mifepristone 200 mg tablet, a progesterone blocker taken with misoprostol for medication abortion^[1]
Generic of Mifeprex (NDA 020687), dispensed only under the Mifepristone REMS Program's certified prescriber and pharmacy rules^[1]

@HealthDesk

参考资料 4可信度 83%

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%
accessdata.fda.gov/drugsatfda_docs/appletter/2025/216616s000ltr.pdf
accessdata.fda.gov· 发布于 2026年9月25日· 开始 2025年9月30日 ✓· 占评分 48%
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".
[2]75%
Louisiana v. FDA: Access to Mifepristone Back at the Supreme Court (KFF)
kff.org· 发表于 2026年5月6日· 占评分 28%
Names Danco, GenBioPro and Evita Solutions as the three mifepristone makers, and quotes FDA's^[1] September 2025 review announcement citing the "lack of adequate consideration underlying the prior REMS approvals".
[3]75%
FDA approves new, generic form of abortion pill (ABC News)
youtube.com· 发表于 2025年10月3日· 占评分 12%
ABC News: the FDA^[1] approved a second generic version of mifepristone as Health Secretary Robert F. Kennedy Jr. pledged to investigate abortion medication.
[4]85%
FDA quietly approved a generic abortion pill ahead of shutdown (NBC News)
nbcnews.com· 发表于 2025年10月2日· 占评分 12%
Reports the Tuesday approval, that Evita's is the second generic after GenBioPro's in 2019, that Evita expected the product in January 2026, and that it came less than two weeks after Kennedy and Makary told state attorneys general the FDA^[1] would review mifepristone's safety.

建议更正

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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.
0.73
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.
0.71
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.
0.68
法律2026/09/25@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
开始于 2024/06/13已确认可信度 84%2.3年前The 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.
0.67
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.
0.67
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%。
0.67
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.
0.67
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.
0.66
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。
0.66
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。
0.65
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。
0.65
健康2026/09/23@HealthDesk
礼来在米兰 EASD 2026 年会上公布 eloraTZP 二期结果
Allianz MiCo, Via Demetrio Stratos, Bolla, Milan, Lombardy 20149, ItalyEli Lilly
开始于 2026/09/30 14:30已排期可信度 86%5天后礼来的新闻稿列出“EloraTZP 专题研讨会 | 2026 年 9 月 30 日，星期三 | 欧洲中部夏令时间下午 4:30 至 5:30”，EASD^[2] 2026 最终日程也将该场次安排在 9 月 30 日（星期三）16:30 - 17:30，地点为布达佩斯厅。
礼来每周一次的胰淀素类药物 eloralintide 与替尔泊肽（Mounjaro、Zepbound）联用的 eloraTZP，首次公布在患有肥胖或超重且合并 2 型糖尿病的成人中的二期结果，于米兰 EASD 胰淀素专题研讨会上亮相。
0.65

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Notable features

参考资料 4可信度 83%

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评论

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