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

Dans le même genre

• Santé23/09/2026@HealthDesk

  FDA Approves Abbott's TactiFlex Duo Ablation Catheter

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

  Commence le 08/09/2026CONFIRMÉCONFIANCE 86 %il y a 15 joursThe 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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• Santé23/09/2026@HealthDesk

  FDA Authorizes Abbott's Libre Duo Glucose-Ketone Sensor

  Abbott Laboratories·…1360 South Loop Road, Alameda, Alameda County, California, 94502, United States

  Commence le 25/08/2026CONFIRMÉCONFIANCE 87 %il y a 29 joursThe 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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• Santé23/09/2026@HealthDesk

  La FDA approuve Inluriyo de Lilly associé à Verzenio contre le cancer du sein muté ESR1

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

  Commence le 18/09/2026CONFIRMÉCONFIANCE 85 %il y a 5 joursLe communiqué de Lilly porte la mention "INDIANAPOLIS, 18 septembre 2026" et indique qu'il "a annoncé aujourd'hui que la Food and Drug Administration (FDA^[4]) américaine a accordé une approbation complète" ; l'avis de la FDA elle-même fixe la date d'approbation au 18 septembre 2026.

  Une association entièrement orale qui a doublé la survie médiane sans progression, de 5,5 à 11,1 mois, chez les patientes mutées ESR1 dans l'essai EMBER-3. C'est la deuxième approbation de la FDA pour Inluriyo en moins d'un an.

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• Santé20/09/2026@HealthDesk

  Ibuzatrelvir's Phase 3 Trial in COVID-19 SARS-CoV-2 Infection Reads Out

  Pfizer·…New York City, New York, United States

  Commence le 03/10/2027ESTIMÉCONFIANCE 50 %l’année prochaineClinicalTrials.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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• Santé23/09/2026@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

  Commence le 31/03/2027ESTIMÉ3 mois de retardCONFIANCE 77 %dans 189 joursLilly "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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• Santé23/09/2026@HealthDesk

  La FDA approuve le système Volt PFA d'Abbott contre la fibrillation atriale

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

  Commence le 22/12/2025CONFIRMÉCONFIANCE 84 %il y a 275 joursLe communiqué porte la mention "ABBOTT PARK, Ill., 22 décembre 2025" et indique qu'Abbott "a annoncé aujourd'hui" que la FDA^[5] a approuvé le Volt PFA System (le registre de la FDA donne quant à lui une date de décision au 19/12/2025).

  La FDA a approuvé le système d'ablation par champ pulsé Volt d'Abbott, un cathéter à ballonnet dans panier qui cartographie, stimule et ablate, pour traiter la fibrillation atriale paroxystique et persistante. L'approbation s'appuie sur l'étude VOLT-AF IDE menée auprès de 392 patients dans 40 centres.

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• Santé20/09/2026@HealthDesk

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

  RocheBasel, Canton of Basel-Stadt, Switzerland

  Commence le 24/07/2028ESTIMÉCONFIANCE 50 %dans 1,8 anClinicalTrials.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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• Santé20/09/2026@HealthDesk

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

  AstraZeneca·…Cambridge, United Kingdom

  Commence le 05/07/2028ESTIMÉCONFIANCE 50 %dans 1,8 anClinicalTrials.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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• Santé20/09/2026@TechDesk

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

  Eli Lilly·…Indianapolis, Indiana

  Commence le 01/04/2026CONFIRMÉCONFIANCE 85 %il y a 175 joursLilly^[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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• Santé20/09/2026@HealthDesk

  BGF MDI 320/14.4/9.6 μG's Phase 3 Trial in COPD Reads Out

  AstraZeneca·…Cambridge, United Kingdom

  Commence le 03/12/2027ESTIMÉCONFIANCE 50 %dans 1,2 anClinicalTrials.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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• Santé20/09/2026@HealthDesk

  BI 690517's Phase 3 Trial in Kidney Disease, Chronic Reads Out

  Boehringer IngelheimIngelheim am Rhein, Mainz-Bingen district, Germany

  Commence le 30/08/2028ESTIMÉCONFIANCE 50 %dans 1,9 anClinicalTrials.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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• Santé20/09/2026@HealthDesk

  Tozorakimab's Phase 3 Trial in Viral Lung Infection and Acute Respiratory Failure Reads Out

  AstraZeneca·…Cambridge, United Kingdom

  Commence le 04/11/2027ESTIMÉCONFIANCE 50 %dans 1,1 anClinicalTrials.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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