VELA: Phase 3 Data Suggest Sonelokimab Effective for HS, With Alexa Kimball, MD, MPH

2026 American Academy of Dermatology (AAD) Annual Meeting

 suggest sonelokimab may deliver sustained clinical and quality-of-life improvements for adults with moderate-to-severe hidradenitis suppurativa (HS).

These findings resulted from the phase 3 VELA-1 and VELA-2 trials. In an on-site interview, VELA trial investigator Alexa Kimball, MD, MPH, of Harvard Medical School, discussed the broader implications of these findings, including how higher response thresholds like Hidradenitis Suppurativa Clinical Response (HiSCR) 75 may help redefine treatment goals and expectations in HS management.

“What was great to see in the data…is that the efficacy seems to be quite have a very high slope at the beginning of treatment and then continues to improve over time through Week 40 with hidradenitis suppurativa,” Kimball expressed.

838 individuals were assessed in the global VELA program, with investigators utilizing the more stringent HiSCR 75 as their primary endpoint, reflecting at least a 75% reduction in patients’ abscess and inflammatory nodule count without worsening of abscesses or draining tunnels. Kimball et al found, by Week 40, approximately 62% of those on sonelokimab attained HiSCR75, with up to 32% achieving complete lesion clearance (HiSCR100).

These findings were described as consistent across both analyses, suggesting a high level of durable disease control with the drug’s use. Additional measures of HS severity and symptom burden also demonstrated meaningful improvement, Kimball and colleagues found. Up to 77% of those evaluated achieved at least a 55% reduction in International HS Severity Scoring System (IHS4-55), and approximately a quarter reached inflammatory remission. Such outcomes point to substantial reductions in inflammatory activity.

Notably, Kimball and coauthors’ clinical gains were accompanied by notable improvements in the patient-reported outcomes seen in the VELA program. Quality-of-life scores, as determined by the HS Quality of Life (HiSQOL) instrument, were found to have risen significantly through the 40-week mark, with many individuals on the drug transitioning from severe baseline impairment to mild or no impact.

Additionally, the investigators noted improvements across key functional and emotional domains, including mobility, pain, and mood. Kimball and colleagues also found up to 43% of subjects reported clinically meaningful reductions in their level of pain, and roughly two-thirds achieved meaningful improvements in Dermatology Life Quality Index (DLQI) scores.

The safety profile of this medication was shown to be consistent with earlier findings, with Kimball et al finding no new safety signals over 40 weeks of treatment.

Kimball’s institution received grants from Abbvie, Admirx, Anapyts Bio, Aristea, Bristol Myers Squibb, Chemocentryx, Eli Lilly, Incyte, Janssen, MoonLake, Novartis, Pfizer, Prometheus, UCB; Sonoma Bio. Kimball received consulting fees from Abbvie, Alumis, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Janssen, Moonlake Novartis, Pfizer, Priovant, Sonoma Bio, Sanofi, UCB; Target RWE, Ventyx; and serves on the board of directors of Almirall.

MoonLake announces Week 40 Results from its Phase 3 Clinical Trials of Sonelokimab in Hidradenitis Suppurativa at the 2026 AAD Annual Meeting. MoonLake. March 28, 2026. Accessed March 30, 2026. 

https://www.globenewswire.com/news-release/2026/03/28/3264203/0/en/MoonLake-announces-Week-40-Results-from-its-Phase-3-Clinical-Trials-of-Sonelokimab-in-Hidradenitis-Suppurativa-at-the-2026-AAD-Annual-Meeting.html

Kimball A. Sonelokimab in moderate-to-severe HS: long-term results through week 40 of two phase 3 trials. Presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO.

Videos

David Cherney, MD, PhD, is Professor of Medicine and Gabor Zellerman Chair of Nephrology Research, University of Toronto. He is a Clinician Scientist in the Division of Nephrology at the University Health Network and Mount Sinai Hospitals and Director of the Renal Physiology Laboratory at UHN.

Kidney Compass: REMODEL Trial Provides Mechanistic Rationale for Semaglutide in CKD

At the World Congress of Nephrology 2026 in Yokohama, Japan, growing attention is being paid not just to whether therapies improve outcomes in chronic kidney disease, but how they work at a mechanistic level. In this episode of 

, host Brendon Neuen, MBBS, PhD, spoke with David Cherney, MD, PhD, about the REMODEL trial, a mechanistic study designed to better understand the kidney-protective effects of semaglutide in patients with type 2 diabetes and chronic kidney disease.

As Cherney explained during the discussion, REMODEL was conceived as a companion to the landmark FLOW trial, which demonstrated significant reductions in cardiorenal outcomes with semaglutide. While FLOW established clinical efficacy, Cherney emphasized that REMODEL was designed to answer a different question: why these benefits occur. Both he and Neuen highlighted that prior analyses suggested the observed kidney protection could not be fully explained by traditional risk factor improvements such as glycemic control, weight loss, or blood pressure reduction.

To address this, Cherney described how REMODEL incorporated a range of advanced imaging and biomarker-based endpoints. The primary outcome focused on MRI-derived measures of kidney oxygenation, while secondary endpoints included albuminuria, kidney function, and a suite of mechanistic markers such as fibrosis, intrarenal fat, and inflammatory pathways. A subset of participants also underwent paired kidney biopsies, allowing for direct assessment of cellular and molecular changes within the kidney.

According to Cherney, the trial did not demonstrate an effect on kidney oxygenation, but did reveal several other important mechanistic signals. He noted that semaglutide led to a reduction in perirenal and hilar fat, a finding that Neuen highlighted as particularly intriguing given emerging hypotheses around the role of local adiposity in kidney injury. Cherney also pointed to improvements in markers of fibrosis and inflammation, including changes in endothelial cell biology and reductions in inflammatory cell populations, suggesting a direct intrarenal effect.

The conversation explored these findings in greater depth, with Neuen raising the possibility that perirenal fat may contribute to kidney injury through both mechanical and inflammatory mechanisms. In response, Cherney outlined multiple potential pathways, including physical compression of renal structures and the metabolic activity of adipose tissue driving cytokine-mediated injury. Both emphasized that these hypotheses warrant further investigation but may represent an underappreciated contributor to disease progression.

Clinically, Cherney reported that semaglutide reduced albuminuria by approximately 40%, reinforcing its potential as a kidney-protective therapy. He also presented subgroup analyses from the REMODEL trial showing consistent effects regardless of baseline use of SGLT2 inhibitors. Neuen noted that this finding aligns with broader evidence suggesting additive and complementary mechanisms between these drug classes, supporting their combined use in high-risk patients.

Looking ahead, both speakers emphasized the broader implications of these findings. Cherney suggested that the mechanisms observed in REMODEL, particularly those related to inflammation and endothelial dysfunction, are likely not specific to diabetes and may extend to non-diabetic kidney disease. He also stressed the importance of reframing semaglutide as a kidney-directed therapy, independent of its effects on glucose or weight, a point Neuen reinforced as critical for both clinicians and patients.

Relevant disclosures for Neuen include AstraZeneca, Bayer, Boehringer Ingelheim, Janssen, and others. Relevant disclosures for Cherney include Boehringer Ingelheim-Lilly, Merck, AstraZeneca, Sanofi, Abbvie, Janssen, AMGEN, Bayer, , Gilead, CSL-Behring, Otsuka, Novartis, GSK, and others.

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David Cherney, MD, PhD, discusses REMODEL trial insights into how semaglutide reduces albuminuria and impacts kidney fat and fibrosis pathways.

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Kidney Compass: Navigating Clinical Trials

Hosted by Brendon Neuen, MBBS, PhD, and Shikha Wadhwani, MD, MS, Kidney Compass: Navigating Clinical Trials is a regular podcast exploring and breaking down the latest updates and nuances of clinical trials in nephrology. By listening to Kidney Compass, you'll get the guidance you need to navigate the changing landscape of clinical trials across the spectrum of kidney disease. 

Martin de Borst, MD, PhD, is consultant nephrologist at the University Medical Center Groningen and adjunct professor of medicine at the University of Groningen.

Kidney Compass: IV Iron and Functional Outcomes in Kidney Transplant Recipients

Iron deficiency is increasingly recognized as a clinically meaningful yet underexplored contributor to morbidity in kidney disease, extending beyond its traditional association with anemia. In populations such as kidney transplant recipients, where graft function may be stable, many patients continue to experience impaired physical function, reduced quality of life, and lingering fatigue.

As evidence from other fields, particularly cardiology, has begun to demonstrate the benefits of intravenous iron on functional outcomes independent of hemoglobin, questions are emerging about whether similar strategies could improve how patients with kidney disease feel and function, not just how they measure on laboratory parameters.

In this episode of Kidney Compass recorded on-site at World Congress of Nephrology in Yokohama, Japan, hosts Shikha Wadhwani, MD, MS, and Brendon Neuen, MBBS, PhD, spoke with Martin de Borst, MD, PhD, about his investigator-initiated randomized trial of intravenous iron in kidney transplant recipients.

Throughout the conversation, de Borst emphasized that the study was motivated by a gap between clinical perception and patient experience. While kidney transplant recipients are often thought to do well, he noted that a subset of patients continue to experience reduced exercise capacity, approximately 20% lower than healthy individuals on average. At the same time, iron deficiency remains common in this population, affecting roughly 1 in 5 patients.

Drawing on prior observational work, de Borst explained that iron deficiency had been associated with worse outcomes across multiple domains, including physical function, quality of life, and cognitive performance, raising the question of whether these relationships were causal.

Neuen reinforced that iron’s biological role extends well beyond erythropoiesis, highlighting its importance in mitochondrial function and muscle performance, while Wadhwani underscored the novelty of focusing on functional endpoints rather than traditional kidney metrics. As de Borst described, the trial was designed with a primary endpoint of the 6-minute walk test, selected for its practicality and reproducibility in a multicenter setting, alongside a broad range of secondary outcomes including neurocognitive testing, quality of life assessments, and cardiac imaging.

The study enrolled 148 stable kidney transplant recipients with iron deficiency, irrespective of hemoglobin levels, and randomized them to receive intravenous ferric carboxymaltose or placebo over a 24-week period. According to de Borst, the results showed modest improvements in exercise capacity. Of note, these improvements were observed in both the treatment and placebo groups, with no significant difference between them. He further noted that secondary outcomes, including cognitive function, cardiac parameters, and quality of life, were similarly neutral.

Despite these findings, de Borst pointed out that biochemical markers of iron status improved substantially in the treatment arm, indicating that while iron stores were corrected, this did not translate into measurable clinical benefit in this population. He also highlighted a small, unexpected signal suggesting a potential improvement in kidney function, though he cautioned that this finding requires further investigation.

The discussion then turned to how these results should be interpreted. Neuen raised the possibility of a ceiling effect, noting that patients in the trial were relatively high functioning at baseline, which may have limited the ability to detect meaningful improvements. De Borst agreed, explaining that while participants had some impairment compared with predicted values, they were not as severely affected as populations in which intravenous iron has shown benefit, such as heart failure.

Looking back, de Borst reflected that selecting a more symptomatic population or one with greater baseline functional limitation may have yielded different results. Both hosts emphasized that this highlights the challenges of trial design in relatively stable transplant populations and the importance of aligning endpoints with patient characteristics.

The conversation expanded beyond the trial itself to broader implications for the field. Neuen stressed that unlike cardiology, where intravenous iron has demonstrated benefits on functional outcomes, nephrology has remained largely focused on hemoglobin-based endpoints. He and de Borst both suggested that this paradigm may need to shift, particularly in non-dialysis chronic kidney disease populations where symptom burden is high and data on patient-centered outcomes remain limited.

Wadhwani echoed this perspective, noting the growing need to better understand how therapies impact how patients feel and function, not just traditional laboratory measures.

Editors’ note: Relevant disclosures for Neuen include AstraZeneca, Bayer, Boehringer Ingelheim, Janssen, and others. Relevant disclosures for Wadhwani include Boehringer Ingelheim, Calliditas Therapeutics, GSK, Otsuka Pharmaceutical Co., Travere Therapeutics, and others. De Borst reports no relevant disclosures.

Martin de Borst, MD, PhD, discusses IV iron use in transplant recipients through an RCT focused on exercise capacity, function, and quality of life.

Katherine Tuttle, MD, is Executive Director for Research at Providence Inland Northwest Health and Professor of Medicine at the University of Washington.

From FLOW to REMODEL: Understanding Semaglutide in CKD, With Katherine Tuttle, MD

Chronic kidney disease (CKD) in the setting of type 2 diabetes represents one of the most high-risk clinical scenarios in medicine, driven not only by progression to kidney failure but by a substantial burden of cardiovascular morbidity and premature death.

While recent therapeutic advances have improved outcomes, understanding how these treatments exert their benefits has remained a critical gap. The REMODEL trial was designed to address this question, offering a detailed mechanistic complement to landmark outcome data on semaglutide’s benefit in this patient population.

 at the World Congress of Nephrology (WCN) in Yokohama, Japan, Katherine Tuttle, MD, explained that REMODEL builds on the success of the FLOW trial, which demonstrated significant reductions in kidney events, cardiovascular outcomes, and all-cause mortality with semaglutide, ultimately leading to the agent’s US Food and Drug Administration approval for this indication. While those findings established clinical efficacy, they did not fully explain the underlying biology. REMODEL, she explains, was specifically designed as a mechanistic “deep dive,” integrating advanced imaging, kidney biopsy, and transcriptomic analyses to uncover how these benefits are achieved.

The study confirmed key clinical findings, including a 40% reduction in albuminuria and stabilization of kidney function. Of note, functional MRI revealed significant reductions in kidney fat far exceeding overall weight loss as well as improved vascular health, reflected by decreased renal arterial resistance. Markers of fibrosis progression were halted in the treatment group, suggesting a protective structural effect.

Biopsy data provided further depth. Tuttle highlights a marked reduction in peri-glomerular immune cells, particularly natural killer T cells, alongside broad downregulation of fibroinflammatory pathways, pointing to a direct anti-inflammatory effect within the kidney microenvironment. Transcriptomic analyses additionally identified glomerular endothelial cells as a key site of regulation, supporting the concept of improved integrity of the glomerular filtration barrier and even evidence of repair, not just stabilization, over time.

She emphasizes that these results align closely with preclinical models, strengthening confidence in translational research approaches. Beyond individual findings, the study design itself represents a major advance, demonstrating that rigorous mechanistic trials can be successfully conducted in humans.

Looking ahead, Tuttle underscores the implications for precision medicine. While current therapies are broadly applied, variability in response remains a major challenge. By linking mechanistic signatures to treatment outcomes, REMODEL provides a framework for identifying responders and tailoring therapy. Ultimately, she suggests, this approach could shift care toward selecting the right treatment for the right patient at the right time, marking a significant step forward in the management of diabetic kidney disease.

Editors’ note: relevant disclosures for Tuttle include Eli Lilly and Company, Boehringer Ingelheim, Astra Zeneca, Gilead, Goldfinch Bio, Novo Nordisk, Travere Therapeutics, and Bayer.

Campbell P. Semaglutide 1.0 mg (Ozempic) Reduced Kidney Events 24% in FLOW Trial. HCPLive. March 5, 2024. Accessed March 31, 2026. 

https://www.hcplive.com/view/semaglutide-1-0-mg-ozempic-reduced-kidney-events-24-in-flow-trial

Brooks A. FDA Approves Semaglutide (Ozempic) for Type 2 Diabetes, Chronic Kidney Disease. HCPLive. January 28, 2025. Accessed March 31, 2026. 

https://www.hcplive.com/view/fda-approves-semaglutide-ozempic-type-2-diabetes-chronic-kidney-disease

Pruijm M, Belmar N, Bjornstad P, et al. REMODELing mechanistic trials for kidney disease: a multimodal, tissue-centered approach to understand the renal mechanism of action of semaglutide. 

REMODEL reveals how semaglutide protects kidneys, showing reduced inflammation, improved vascular health, and evidence of structural repair in diabetic CKD.

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The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

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TRACE: Tralokinumab Data for Atopic Dermatitis in Skin of Color, With April Armstrong, MD, MPH

A new post-hoc analysis from the TRACE study suggests 80.4% of patients with skin of color and atopic dermatitis who were involved in the study achieved at least 1 clinically meaningful disease control endpoint at 12 months of use.

This post-hoc analysis was 1 of several from the TRACE study presented at the 

. The data was authored by investigators such as April Armstrong, MD, MPH, of UCLA’s David Geffen School of Medicine, who spoke with 

 about these new findings on tralokinumab, providing important real-world insights into the long-term effectiveness of tralokinumab in adults with atopic dermatitis.

“The TRACE study is a real world study looking at patients with moderate to severe atopic dermatitis who started on tralokinumab, and the unique aspect about this particular study is that it recruited globally and [used] a patient population,” Armstrong explained.

The study is a prospective, non-interventional, international study designed to assess outcomes over 12 months in those using tralokinumab in routine clinical practice. In 1 piece of data highlighted at the meeting, patients with baseline head and neck involvement (n=495) saw substantial and sustained disease improvement over time.

Specifically, the proportion of those reporting any head and neck involvement dipped from baseline to 46.3% at Month 3 and dipped further to 31.6% at Month 12. The investigators noted such improvements were accompanied by early and clinically meaningful gains in symptom burden and disease severity, including reductions in Peak Pruritus and Sleep Numerical Rating Scale (PP/Sleep-NRS) scores, Investigator’s Global Assessment (IGA) scores, and Dermatology Life Quality Index (DLQI) score improvements.

In the separate subgroup analysis described by Armstrong, regarding 131 patients with skin of color (Fitzpatrick skin types IV–VI), 80.4% attained at least a single clinically meaningful disease control endpoint by the 12-month mark. These endpoints included IGA 0/1, EASI ≤7, or SCORAD <10, suggesting minimal to mild disease. Observance of quality of life improvements also took place in this population.

“What we found is that, among patients who were classified as skin of color, about 80% of them are able to achieve that stringent endpoint by 12 months,” Armstrong said. “And importantly, for that particular endpoint looking at the difference between, for example, patients who are skin of color with the overall population, the difference was actually very small.”

Across the overall study population (n=824), Armstrong et al found 91% of patients achieved at least 1 moderate treatment target after 12 months of tralokinumab use. Notably, approximately three-quarters met both clinician-reported and patient-reported moderate endpoints. The team also found nearly half attained optimal targets consistent with minimal disease activity.

For any additional information on these data, view Armstrong’s full interview posted above.

The quotes used in this summary were edited for clarity.

Armstrong has served as a consultant for and received honoraria from AbbVie, Almirall, Arcutis, ASLAN, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira, EPI, Incyte, Janssen, LEO Pharma, Eli Lilly, Nimbus, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, Sun, and UCB and has participated in advisory boards for Boehringer Ingelheim and Parexel.

LEO Pharma Presents New 12-Month Real-World Data for Tralokinumab at AAD 2026. LEO Pharma. May 30, 2026. 

https://www.businesswire.com/news/home/20260328143419/en/LEO-Pharma-Presents-New-12-Month-Real-World-Data-for-Tralokinumab-at-AAD-2026

Armstrong AW, Rubin C, Jarell A, et al. Real-world effectiveness of 12 months tralokinumab treatment in patients with skin of color and moderate-to-severe atopic dermatitis: final data from the prospective, non-interventional, international TRACE study. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 77199. Oral Poster Presentation.

This interview highlights new 12-month, real-world data on tralokinumab and its long-term efficacy in patients with skin of color who live with atopic dermatitis.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

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The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Thierry Passeron, MD, PhD, is a professor and chair of the Department of Dermatology at the Université Côte d'Azur in Nice, France.

Patients with non-segmental vitiligo (NSV) on upadacitinib versus placebo showed continuous improvement over 48 weeks with no plateau.

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Upadacitinib Safe, Effective Over 48 Weeks for Non-Segmental Vitiligo, With Thierry Passeron, MD, PhD

Dominic Sisti, PhD, is an associate professor in the Department of Medical Ethics & Health Policy and the director of the Scattergood Program for the Applied Ethics of Behavioral Health Care. Sisti is also the host of 

, our monthly multimedia series on medical ethics in modern healthcare. 

As patients increasingly turn to ChatGPT for mental health support, psychiatrists and ethicists weigh the clinical risks, ethical concerns, and what clinicians should do next.

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Your Patient's New Therapist Is an AI. Now What?

Patrick Campbell is the editorial director of HCPLive. Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter and/or multimedia specialist with the Pocono Record, Star News Group, and NJ Advance Media. He is the executive producer for multiple HCPLive podcasts, including Diabetes Dialogue, Don't Miss a Beat, Kidney Compass, Medical Ethics Unpacked, The Medical Sisterhood, and Skin of Color Savvy. 


Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

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New information from the phase 3 SCOUT-HCM trial indicate the benefits of mavacamten may extend to adolescents as well as adults. 

Cardiomyopathy

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Mavacamten Shows Benefit for Pediatric Patients in SCOUT-HCM Trial

Chovatiya discussed new data showing significant EASI improvements across moderate and severe atopic dermatitis.

REZOLVE-AD: Rezpegaldesleukin Shows Consistent Efficacy Across Atopic Dermatitis Severity, With Raj Chovatiya, MD, PhD

Victoria Johnson joined MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and is now an assistant managing editor for HCPLive and RheumatologyLive. She doesn’t have enough time for her numerous hobbies. You can reach her at vjohnson@mjhlifesciences.com.

Results from the phase 3 trial were published in NEJM and simultaneously presented as a late-breaking abstract at AAD 2026.

VALOR: Brepocitinib AAD Data Support Priority Review for Dermatomyositis

Nicholas Marston, MD, MPH, is a cardiologist and an assistant professor of medicine at Brigham and Women's Hospital.

Marston discusses his sub analysis of the VESALIUS-CV trial, which indicated reduced MACE risk in patients with diabetes and no atherosclerosis after evolocumab treatment.

Atherosclerotic Cardiovascular Disease

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Evolocumab Reduces CV Risk in Non-Atherosclerotic Patients With Diabetes, With Nicholas Marston, MD, MPH

Layla Van Doren, MD, MBA, is an assistant professor of medicine at Yale School of Medicine and a classical hematologist at Smilow Cancer Hospital.

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Burnout in Sickle Cell Physicians Hits 60% While Grit and Resilience Stand Strong

Linda Stein Gold, MD, is a dermatologist at Henry Ford Health. 

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Luisa Campos, Global Heme Lead, Medical & Scientific Affairs at Thermo Fisher Scientific.

Rapid NGS and streamlined workflows are critical to delivering timely, actionable genomic insights in blood cancers, but access, reimbursement, and expertise gaps persist.

Timing Is Everything: Advancing Genomic Testing in Hematologic Malignancies

In the first study of its kind, researchers found that physicians treating sickle cell disease experience burnout at a rate of 60% — driven not by personal factors, but by systemic ones. 


Latest News

VELA: Phase 3 Data Suggest Sonelokimab Effective for HS, With Alexa Kimball, MD, MPH

Kidney Compass: REMODEL Trial Provides Mechanistic Rationale for Semaglutide in CKD

Kidney Compass: IV Iron and Functional Outcomes in Kidney Transplant Recipients

From FLOW to REMODEL: Understanding Semaglutide in CKD, With Katherine Tuttle, MD

TRACE: Tralokinumab Data for Atopic Dermatitis in Skin of Color, With April Armstrong, MD, MPH