Health09/23/2026@HealthDesk
FDA Approves Abbott's TactiFlex Duo Ablation Catheter
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
Starts 09/08/2026CONFIRMED 86% CONFIDENCE15 days agoThe 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
Health09/23/2026@HealthDesk
FDA Authorizes Abbott's Libre Duo Glucose-Ketone Sensor
Abbott Laboratories…1360 South Loop Road, Alameda, Alameda County, California, 94502, United States
Starts 08/25/2026CONFIRMED 87% CONFIDENCE29 days agoThe 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
Health09/23/2026@HealthDesk
FDA Approves Lilly's Inluriyo With Verzenio for ESR1-Mutated Breast Cancer
Eli Lilly…Bowditch Road, Federal Research Center, Hillandale, Montgomery County, Maryland, 20993, United States
Starts 09/18/2026CONFIRMED 85% CONFIDENCE5 days agoLilly's release is datelined "INDIANAPOLIS, Sept. 18, 2026" and says it "announced today that the U.S. Food and Drug Administration (FDA^[4]) has granted full approval"; the FDA's own notice gives the approval date as September 18, 2026.
An all-oral pairing that doubled median progression-free survival to 11.1 months from 5.5 in ESR1-mutated patients in the EMBER-3 trial. It is Inluriyo's second FDA approval in under a year.
0.64
Health09/20/2026@HealthDesk
Ibuzatrelvir's Phase 3 Trial in COVID-19 SARS-CoV-2 Infection Reads Out
Pfizer…New York City, New York, United States
Starts 10/03/2027ESTIMATED 50% CONFIDENCEin 1.0 yearsClinicalTrials.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
Health09/23/2026@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
Starts 03/31/2027ESTIMATED3 months late77% CONFIDENCEin 189 daysLilly "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
Health09/23/2026@HealthDesk
FDA Approves Abbott's Volt PFA System for AFib
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
Starts 12/22/2025CONFIRMED 84% CONFIDENCE275 days agoThe release is datelined "ABBOTT PARK, Ill., Dec. 22, 2025" and says Abbott "today announced" the FDA^[5] has approved the Volt PFA System (the FDA's own record gives a decision date of 12/19/2025).
The FDA approved Abbott's Volt pulsed field ablation system, a balloon-in-basket catheter that maps, paces and ablates, to treat paroxysmal and persistent atrial fibrillation. The approval rested on the 392-patient VOLT-AF IDE study at 40 centers.
0.63
Health09/20/2026@HealthDesk
Enicepatide's Phase 3 Trial in Obesity or Overweight Reads Out
RocheBasel, Canton of Basel-Stadt, Switzerland
Starts 07/24/2028ESTIMATED 50% CONFIDENCEin 1.8 yearsClinicalTrials.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
Health09/20/2026@HealthDesk
Elecoglipron's Phase 3 Trial in Type 2 Diabetes Mellitus Reads Out
AstraZeneca…Cambridge, United Kingdom
Starts 07/05/2028ESTIMATED 50% CONFIDENCEin 1.8 yearsClinicalTrials.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
Health09/20/2026@TechDesk
Lilly's Foundayo (Orforglipron) Weight-Loss Pill Approved by FDA
Eli Lilly…Indianapolis, Indiana
Starts 04/01/2026CONFIRMED 85% CONFIDENCE175 days agoLilly^[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
Health09/20/2026@HealthDesk
BGF MDI 320/14.4/9.6 μG's Phase 3 Trial in COPD Reads Out
AstraZeneca…Cambridge, United Kingdom
Starts 12/03/2027ESTIMATED 50% CONFIDENCEin 1.2 yearsClinicalTrials.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
Health09/20/2026@HealthDesk
BI 690517's Phase 3 Trial in Kidney Disease, Chronic Reads Out
Boehringer IngelheimIngelheim am Rhein, Mainz-Bingen district, Germany
Starts 08/30/2028ESTIMATED 50% CONFIDENCEin 1.9 yearsClinicalTrials.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
Health09/20/2026@HealthDesk
Tozorakimab's Phase 3 Trial in Viral Lung Infection and Acute Respiratory Failure Reads Out
AstraZeneca…Cambridge, United Kingdom
Starts 11/04/2027ESTIMATED 50% CONFIDENCEin 1.1 yearsClinicalTrials.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".

Start: Mar 17, 202695% CONFIDENCEfrom 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

References 488% CONFIDENCE

The first entry is always the pin's source. Overall confidence is a weighted average of how firmly each reference supports the start and end times used above; a reference counts half as much for every 180 days older than the newest.

[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· Posted Sep 23, 2026· Starts Mar 17, 2026· 41% of score
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· Published Mar 18, 2026· 20% of score
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· Published Mar 18, 2026· 20% of score
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· Published Mar 17, 2026· Starts Mar 17, 2026 ✓· 20% of score
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 Psoriasisstart was $238.11

Health09/23/2026@HealthDesk
FDA Approves Abbott's TactiFlex Duo Ablation Catheter
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
Starts 09/08/2026CONFIRMED 86% CONFIDENCE15 days agoThe 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
Health09/23/2026@HealthDesk
FDA Authorizes Abbott's Libre Duo Glucose-Ketone Sensor
Abbott Laboratories…1360 South Loop Road, Alameda, Alameda County, California, 94502, United States
Starts 08/25/2026CONFIRMED 87% CONFIDENCE29 days agoThe 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
Health09/23/2026@HealthDesk
FDA Approves Lilly's Inluriyo With Verzenio for ESR1-Mutated Breast Cancer
Eli Lilly…Bowditch Road, Federal Research Center, Hillandale, Montgomery County, Maryland, 20993, United States
Starts 09/18/2026CONFIRMED 85% CONFIDENCE5 days agoLilly's release is datelined "INDIANAPOLIS, Sept. 18, 2026" and says it "announced today that the U.S. Food and Drug Administration (FDA^[4]) has granted full approval"; the FDA's own notice gives the approval date as September 18, 2026.
An all-oral pairing that doubled median progression-free survival to 11.1 months from 5.5 in ESR1-mutated patients in the EMBER-3 trial. It is Inluriyo's second FDA approval in under a year.
0.64
Health09/20/2026@HealthDesk
Ibuzatrelvir's Phase 3 Trial in COVID-19 SARS-CoV-2 Infection Reads Out
Pfizer…New York City, New York, United States
Starts 10/03/2027ESTIMATED 50% CONFIDENCEin 1.0 yearsClinicalTrials.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
Health09/23/2026@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
Starts 03/31/2027ESTIMATED3 months late77% CONFIDENCEin 189 daysLilly "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
Health09/23/2026@HealthDesk
FDA Approves Abbott's Volt PFA System for AFib
Abbott Laboratories…Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
Starts 12/22/2025CONFIRMED 84% CONFIDENCE275 days agoThe release is datelined "ABBOTT PARK, Ill., Dec. 22, 2025" and says Abbott "today announced" the FDA^[5] has approved the Volt PFA System (the FDA's own record gives a decision date of 12/19/2025).
The FDA approved Abbott's Volt pulsed field ablation system, a balloon-in-basket catheter that maps, paces and ablates, to treat paroxysmal and persistent atrial fibrillation. The approval rested on the 392-patient VOLT-AF IDE study at 40 centers.
0.63
Health09/20/2026@HealthDesk
Enicepatide's Phase 3 Trial in Obesity or Overweight Reads Out
RocheBasel, Canton of Basel-Stadt, Switzerland
Starts 07/24/2028ESTIMATED 50% CONFIDENCEin 1.8 yearsClinicalTrials.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
Health09/20/2026@HealthDesk
Elecoglipron's Phase 3 Trial in Type 2 Diabetes Mellitus Reads Out
AstraZeneca…Cambridge, United Kingdom
Starts 07/05/2028ESTIMATED 50% CONFIDENCEin 1.8 yearsClinicalTrials.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
Health09/20/2026@TechDesk
Lilly's Foundayo (Orforglipron) Weight-Loss Pill Approved by FDA
Eli Lilly…Indianapolis, Indiana
Starts 04/01/2026CONFIRMED 85% CONFIDENCE175 days agoLilly^[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
Health09/20/2026@HealthDesk
BGF MDI 320/14.4/9.6 μG's Phase 3 Trial in COPD Reads Out
AstraZeneca…Cambridge, United Kingdom
Starts 12/03/2027ESTIMATED 50% CONFIDENCEin 1.2 yearsClinicalTrials.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
Health09/20/2026@HealthDesk
BI 690517's Phase 3 Trial in Kidney Disease, Chronic Reads Out
Boehringer IngelheimIngelheim am Rhein, Mainz-Bingen district, Germany
Starts 08/30/2028ESTIMATED 50% CONFIDENCEin 1.9 yearsClinicalTrials.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
Health09/20/2026@HealthDesk
Tozorakimab's Phase 3 Trial in Viral Lung Infection and Acute Respiratory Failure Reads Out
AstraZeneca…Cambridge, United Kingdom
Starts 11/04/2027ESTIMATED 50% CONFIDENCEin 1.1 yearsClinicalTrials.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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