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

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• 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

  開始 2026/09/08確定確度 86%15 日前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.

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• 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

  開始 2026/08/25確定確度 87%29 日前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.

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• 健康2026/09/23@HealthDesk

  FDA、ESR1変異乳がんにリリーのInluriyoとVerzenioの併用を承認

  Eli Lilly·…Bowditch Road, Federal Research Center, Hillandale, Montgomery County, Maryland, 20993, United States

  開始 2026/09/18確定確度 85%5 日前リリーのリリースには「インディアナポリス、2026年9月18日」の発信地・日付があり、「米食品医薬品局（FDA^[4]）が完全承認を与えたと本日発表した」と記されている。FDA自身の告知でも承認日は2026年9月18日とされている。

  EMBER-3試験でESR1変異患者の無増悪生存期間中央値を5.5カ月から11.1カ月へと倍増させた全経口の併用療法。Inluriyoにとって1年足らずで2度目のFDA承認となる。

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• 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

  開始 2027/10/03推定確度 50%来年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.

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• 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

  開始 2027/03/31推定3 か月遅れ確度 77%189 日後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.

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• 健康2026/09/23@HealthDesk

  FDA、アボットの心房細動治療用「Volt」PFAシステムを承認

  Abbott Laboratories·…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States

  開始 2025/12/22確定確度 84%275 日前プレスリリースには「イリノイ州アボットパーク、2025年12月22日」の日付が付され、FDA^[5]がVolt PFA Systemを承認したと「本日発表した」と記されている（FDA自身の記録では決定日は2025年12月19日）。

  FDAは、アボットのパルスフィールドアブレーション（PFA）システム「Volt」を、発作性および持続性心房細動の治療用に承認した。マッピング、ペーシング、アブレーションを行うバルーン・イン・バスケット型カテーテルで、承認は40施設・392人が参加したVOLT-AF IDE試験に基づく。

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• 健康2026/09/20@HealthDesk

  Enicepatide's Phase 3 Trial in Obesity or Overweight Reads Out

  RocheBasel, Canton of Basel-Stadt, Switzerland

  開始 2028/07/24推定確度 50%1.8 年後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.

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• 健康2026/09/20@HealthDesk

  Elecoglipron's Phase 3 Trial in Type 2 Diabetes Mellitus Reads Out

  AstraZeneca·…Cambridge, United Kingdom

  開始 2028/07/05推定確度 50%1.8 年後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.

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• 健康2026/09/20@TechDesk

  Lilly's Foundayo (Orforglipron) Weight-Loss Pill Approved by FDA

  Eli Lilly·…Indianapolis, Indiana

  開始 2026/04/01確定確度 85%175 日前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.

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• 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

  開始 2027/12/03推定確度 50%1.2 年後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.

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• 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

  開始 2028/08/30推定確度 50%1.9 年後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

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• 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

  開始 2027/11/04推定確度 50%1.1 年後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.

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