健康2026/09/23@HealthDesk
FDA Approves Abbott's TactiFlex Duo Ablation Catheter
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2026/09/08已确认可信度 86%15天前The release is datelined "ABBOTT PARK, Ill., Sept. 8, 2026" and says Abbott "announced today it has received U.S. Food and Drug Administration (FDA^[3]) approval" (the FDA's record gives a decision date of 09/04/2026).
The FDA approved Abbott's TactiFlex Duo, a catheter that can deliver pulsed field ablation, radiofrequency energy or both in one procedure to treat complex atrial fibrillation. The approval rested on the FlexPulse IDE study.
0.66
健康2026/09/23@HealthDesk
FDA Authorizes Abbott's Libre Duo Glucose-Ketone Sensor
Abbott Laboratories…1360 South Loop Road, Alameda, Alameda County, California, 94502, United States
开始于 2026/08/25已确认可信度 87%29天前The release is datelined "ABBOTT PARK, Ill., Aug. 25, 2026" and says Abbott "today announced U.S. Food and Drug Administration (FDA^[2][3]) authorization of its Libre Duo 10 Day system"; the FDA's De Novo record gives the same decision date, 08/25/2026.
The FDA authorized Abbott's Libre Duo 10 Day, the first wearable to continuously track both glucose and ketones, which alerts people with diabetes aged 2 and older to rising ketones before diabetic ketoacidosis.
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 Lilly…Bowditch Road, Federal Research Center, Hillandale, Montgomery County, Maryland, 20993, United States
开始于 2026/09/18已确认可信度 85%5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。
0.64
健康2026/09/20@HealthDesk
Ibuzatrelvir's Phase 3 Trial in COVID-19 SARS-CoV-2 Infection Reads Out
Pfizer…New York City, New York, United States
开始于 2027/10/03预估可信度 50%明年ClinicalTrials.gov^[1] lists 2027-10-03 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
Pfizer's phase 3 trial of Ibuzatrelvir in covid-19 sars-cov-2 infection reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 2,330 participants. The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.
0.63
健康2026/09/23@HealthDesk
Lilly Submits Retatrutide to the FDA for Approval
Eli Lilly…Eli 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%189天后Lilly "plans to subsequently submit retatrutide in Q1 2027 for U.S. approval" - no day is given, so the pin takes the last day of the first quarter of 2027.^[1]
Lilly plans to file its Biologics License Application for retatrutide, the triple-hormone obesity shot that cut weight by up to 28.3% in Phase 3, with the FDA in the first quarter of 2027, once its manufacturing data package is complete.
0.63
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 Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2025/12/22已确认可信度 84%275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。
0.63
健康2026/09/20@HealthDesk
Enicepatide's Phase 3 Trial in Obesity or Overweight Reads Out
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] lists 2028-07-24 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
Roche's phase 3 trial of Enicepatide in obesity or overweight reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 2,000 participants. The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.
0.62
健康2026/09/20@HealthDesk
Elecoglipron's Phase 3 Trial in Type 2 Diabetes Mellitus Reads Out
AstraZeneca…Cambridge, United Kingdom
开始于 2028/07/05预估可信度 50%1.8年后ClinicalTrials.gov^[1] lists 2028-07-05 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
AstraZeneca's phase 3 trial of Elecoglipron in type 2 diabetes mellitus reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 2,000 participants. The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.
0.62
健康2026/09/20@TechDesk
Lilly's Foundayo (Orforglipron) Weight-Loss Pill Approved by FDA
Eli Lilly…Indianapolis, Indiana
开始于 2026/04/01已确认可信度 85%175天前Lilly^[3] and the FDA^[4] approval letter date the approval April 1, 2026.
The FDA approved Eli Lilly's Foundayo, a once-daily GLP-1 pill for weight loss that needs no food or water restrictions, with direct-to-consumer sales from April 6.
0.62
健康2026/09/20@HealthDesk
BGF MDI 320/14.4/9.6 μG's Phase 3 Trial in COPD Reads Out
AstraZeneca…Cambridge, United Kingdom
开始于 2027/12/03预估可信度 50%1.2年后ClinicalTrials.gov^[1] lists 2027-12-03 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
AstraZeneca's phase 3 trial of BGF MDI 320/14.4/9.6 μG in copd reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 5,000 participants. This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.
0.61
健康2026/09/20@HealthDesk
BI 690517's Phase 3 Trial in Kidney Disease, Chronic Reads Out
Boehringer IngelheimIngelheim am Rhein, Mainz-Bingen district, Germany
开始于 2028/08/30预估可信度 50%1.9年后ClinicalTrials.gov^[1] lists 2028-08-30 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
Boehringer Ingelheim's phase 3 trial of BI 690517 in kidney disease, chronic reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 11,000 participants. This study is open to adults with chronic kidney disease at risk of progression. People with and without type 2 diabetes can take part in this study. The study is open to people who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor (SGLT2i) can also join. The study is also open to people who currently do not take any of these treatments. The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin. Worsening of kidney function increases the risk for kidney failure, cardiovascular disease, and heart failure hospitalisation. After a run-in period, during which participants are confirmed to be receiving clinical
0.61
健康2026/09/20@HealthDesk
Tozorakimab's Phase 3 Trial in Viral Lung Infection and Acute Respiratory Failure Reads Out
AstraZeneca…Cambridge, United Kingdom
开始于 2027/11/04预估可信度 50%1.1年后ClinicalTrials.gov^[1] lists 2027-11-04 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
AstraZeneca's phase 3 trial of Tozorakimab in viral lung infection and acute respiratory failure reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 3,527 participants. The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.
0.61

The FDA's^[4] approval letter for NDA 220149 says the application "is approved, effective on the date of this letter" and was electronically signed "03/17/2026 04:12:23 PM" (Eastern, 20:12 UTC); J&J announced it the next morning: "SPRING HOUSE, Pa. (March 18, 2026) - ... announced today that the U.S. Food and Drug Administration (FDA) has approved ICOTYDE".

开始: 2026年3月17日可信度 95%来自accessdata.fda.gov

FDA Approves Icotyde, the First Oral IL-23 Receptor Pill for Psoriasis

The FDA approved Johnson & Johnson's Icotyde (icotrokinra), a once-daily pill and the first targeted oral peptide to block the IL-23 receptor, for moderate-to-severe plaque psoriasis in adults and children 12 and older weighing at least 40 kg.

The FDA approved Icotyde (icotrokinra) on 17 March 2026 for moderate-to-severe plaque psoriasis in adults and children 12 and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy^[4].
Johnson & Johnson announced the approval the next morning from Spring House, Pennsylvania, calling Icotyde the first and only targeted oral peptide that precisely blocks the IL-23 receptor, taken as one pill a day on waking^[1].
Across four Phase 3 studies of 2,500 patients in the ICONIC programme, about 70% reached clear or almost clear skin (IGA 0/1) and 55% a PASI 90 response at week 16 in the head-to-head studies, with adverse reactions within 1.1% of placebo^[1].
It is the first oral IL-23-targeting drug on the market; Icotyde beat Bristol Myers Squibb's oral Sotyktu (deucravacitinib) head to head, and Jefferies analysts have put peak sales near $10 billion^[2].
J&J licensed icotrokinra from Protagonist Therapeutics in 2017; Protagonist earns a $50 million milestone for the US approval and 6% to 10% royalties on sales^[2].
Dermatology Times reports that, unlike existing IL-23 drugs that target the cytokine, icotrokinra blocks the receptor itself, bringing biologic-level efficacy to a pill^[3].
Icotyde is also in trials for psoriatic arthritis, ulcerative colitis and Crohn's disease^[1].

@HealthDesk

参考资料 4可信度 88%

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%
jnj.com/media-center/press-releases/fda-approval-of-icotyde-icotrokinra-ushers-in-new-era-for-first-line-systemic-treatment-of-plaque-psoriasis-with-a-targeted-oral-peptide
jnj.com· 发布于 2026年9月23日· 开始 2026年3月17日· 占评分 41%
The FDA's^[4] approval letter for NDA 220149 says the application "is approved, effective on the date of this letter" and was electronically signed "03/17/2026 04:12:23 PM" (Eastern, 20:12 UTC); J&J announced it the next morning: "SPRING HOUSE, Pa. (March 18, 2026) - ... announced today that the U.S. Food and Drug Administration (FDA) has approved ICOTYDE".
[2]85%
J&J gets FDA okay for psoriasis drug icotrokinra (pharmaphorum)
pharmaphorum.com· 发表于 2026年3月18日· 占评分 20%
Independent trade coverage: the first oral IL-23-targeting drug to reach the market, Clarivate's $1.5B 2031 G7 sales forecast, Jefferies' ~$10B peak estimate, and Protagonist's $50M approval milestone and 6-10% royalties.^[1]
[3]82%
FDA Approves Icotrokinra, First Oral IL-23 Receptor Blocker for Psoriasis (Dermatology Times)
dermatologytimes.com· 发表于 2026年3月18日· 占评分 20%
Dermatology trade coverage of the approval with the ICONIC Phase 3 figures (IGA 0/1 ~70%, PASI 90 ~55% at week 16) and comment from its editor-in-chief on the receptor-blocking mechanism.^[1]
[4]95%
NDA 220149 Approval Letter: Icotyde (icotrokinra) tablets (FDA)
accessdata.fda.gov· 发表于 2026年3月17日· 开始 2026年3月17日 ✓· 占评分 20%
The FDA's approval letter to Janssen Biotech (Welsh and McKean Roads, Spring House, PA) approving Icotyde for moderate-to-severe plaque psoriasis in patients 12 and older weighing at least 40 kg, effective on the letter's date, electronically signed 03/17/2026 4:12 PM.

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1FDA Approves Icotyde, the First Oral IL-23 Receptor Pill for Psoriasis开始时为 US$238.11

健康2026/09/23@HealthDesk
FDA Approves Abbott's TactiFlex Duo Ablation Catheter
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2026/09/08已确认可信度 86%15天前The release is datelined "ABBOTT PARK, Ill., Sept. 8, 2026" and says Abbott "announced today it has received U.S. Food and Drug Administration (FDA^[3]) approval" (the FDA's record gives a decision date of 09/04/2026).
The FDA approved Abbott's TactiFlex Duo, a catheter that can deliver pulsed field ablation, radiofrequency energy or both in one procedure to treat complex atrial fibrillation. The approval rested on the FlexPulse IDE study.
0.66
健康2026/09/23@HealthDesk
FDA Authorizes Abbott's Libre Duo Glucose-Ketone Sensor
Abbott Laboratories…1360 South Loop Road, Alameda, Alameda County, California, 94502, United States
开始于 2026/08/25已确认可信度 87%29天前The release is datelined "ABBOTT PARK, Ill., Aug. 25, 2026" and says Abbott "today announced U.S. Food and Drug Administration (FDA^[2][3]) authorization of its Libre Duo 10 Day system"; the FDA's De Novo record gives the same decision date, 08/25/2026.
The FDA authorized Abbott's Libre Duo 10 Day, the first wearable to continuously track both glucose and ketones, which alerts people with diabetes aged 2 and older to rising ketones before diabetic ketoacidosis.
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 Lilly…Bowditch Road, Federal Research Center, Hillandale, Montgomery County, Maryland, 20993, United States
开始于 2026/09/18已确认可信度 85%5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。
0.64
健康2026/09/20@HealthDesk
Ibuzatrelvir's Phase 3 Trial in COVID-19 SARS-CoV-2 Infection Reads Out
Pfizer…New York City, New York, United States
开始于 2027/10/03预估可信度 50%明年ClinicalTrials.gov^[1] lists 2027-10-03 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
Pfizer's phase 3 trial of Ibuzatrelvir in covid-19 sars-cov-2 infection reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 2,330 participants. The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.
0.63
健康2026/09/23@HealthDesk
Lilly Submits Retatrutide to the FDA for Approval
Eli Lilly…Eli 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%189天后Lilly "plans to subsequently submit retatrutide in Q1 2027 for U.S. approval" - no day is given, so the pin takes the last day of the first quarter of 2027.^[1]
Lilly plans to file its Biologics License Application for retatrutide, the triple-hormone obesity shot that cut weight by up to 28.3% in Phase 3, with the FDA in the first quarter of 2027, once its manufacturing data package is complete.
0.63
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 Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
开始于 2025/12/22已确认可信度 84%275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。
0.63
健康2026/09/20@HealthDesk
Enicepatide's Phase 3 Trial in Obesity or Overweight Reads Out
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] lists 2028-07-24 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
Roche's phase 3 trial of Enicepatide in obesity or overweight reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 2,000 participants. The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.
0.62
健康2026/09/20@HealthDesk
Elecoglipron's Phase 3 Trial in Type 2 Diabetes Mellitus Reads Out
AstraZeneca…Cambridge, United Kingdom
开始于 2028/07/05预估可信度 50%1.8年后ClinicalTrials.gov^[1] lists 2028-07-05 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
AstraZeneca's phase 3 trial of Elecoglipron in type 2 diabetes mellitus reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 2,000 participants. The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.
0.62
健康2026/09/20@TechDesk
Lilly's Foundayo (Orforglipron) Weight-Loss Pill Approved by FDA
Eli Lilly…Indianapolis, Indiana
开始于 2026/04/01已确认可信度 85%175天前Lilly^[3] and the FDA^[4] approval letter date the approval April 1, 2026.
The FDA approved Eli Lilly's Foundayo, a once-daily GLP-1 pill for weight loss that needs no food or water restrictions, with direct-to-consumer sales from April 6.
0.62
健康2026/09/20@HealthDesk
BGF MDI 320/14.4/9.6 μG's Phase 3 Trial in COPD Reads Out
AstraZeneca…Cambridge, United Kingdom
开始于 2027/12/03预估可信度 50%1.2年后ClinicalTrials.gov^[1] lists 2027-12-03 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
AstraZeneca's phase 3 trial of BGF MDI 320/14.4/9.6 μG in copd reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 5,000 participants. This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.
0.61
健康2026/09/20@HealthDesk
BI 690517's Phase 3 Trial in Kidney Disease, Chronic Reads Out
Boehringer IngelheimIngelheim am Rhein, Mainz-Bingen district, Germany
开始于 2028/08/30预估可信度 50%1.9年后ClinicalTrials.gov^[1] lists 2028-08-30 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
Boehringer Ingelheim's phase 3 trial of BI 690517 in kidney disease, chronic reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 11,000 participants. This study is open to adults with chronic kidney disease at risk of progression. People with and without type 2 diabetes can take part in this study. The study is open to people who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor (SGLT2i) can also join. The study is also open to people who currently do not take any of these treatments. The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin. Worsening of kidney function increases the risk for kidney failure, cardiovascular disease, and heart failure hospitalisation. After a run-in period, during which participants are confirmed to be receiving clinical
0.61
健康2026/09/20@HealthDesk
Tozorakimab's Phase 3 Trial in Viral Lung Infection and Acute Respiratory Failure Reads Out
AstraZeneca…Cambridge, United Kingdom
开始于 2027/11/04预估可信度 50%1.1年后ClinicalTrials.gov^[1] lists 2027-11-04 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
AstraZeneca's phase 3 trial of Tozorakimab in viral lung infection and acute respiratory failure reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 3,527 participants. The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.
0.61

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参考资料 4可信度 88%

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