Marla Dubinsky, MD, is chief of the division of pediatric gastroenterology and nutrition and co-director of the Susan and Leonard Feinstein IBD Clinical Center, Mount Sinai Kravis Children's Hospital, Icahn School of Medicine.

The Drug Holiday Dilemma in IBD — and How SC Infliximab Changes It

Treatment interruptions with anti-TNFs are common in clinical practice, driven by loss of response, safety concerns, pregnancy, or patient preference. Historically, reintroducing the drug intravenously has carried meaningful risk.

However, new post hoc data from the phase 3 LIBERTY trials suggest that subcutaneous (SC) infliximab may offer a safer, more durable path back to disease control for patients with 

Crohn's disease (CD) or ulcerative colitis (UC)

 following a drug holiday. The analysis was presented by Marla Dubinsky, MD, a gastroenterologist and professor of medicine at the Icahn School of Medicine at Mount Sinai, at Digestive Disease Week (DDW) 2026 in Chicago, IL.

"Historically, about 50% of patients are off anti-TNF therapy over the first 2 to 3 years," Dubinsky told 

. "Before we understood drug levels and antibodies, we just waited for people to lose response and then moved on."Before we understood drug levels, safety, antibodies, there were quite a number of patients who were stopping it, predominantly for loss of response, with a large number of them associated with anti drug antibodies because they were not proactively optimized. We just waited for people to lose response, got a drug level and said ‘You've now got antibodies, I have to move on.’”

The LIBERTY-CD and LIBERTY-UC trials randomly assigned patients who responded to IV infliximab induction to either SC infliximab 120 mg or placebo every other week through week 54. Patients in the placebo arm who experienced disease recurrence after a minimum 16-week drug holiday were eligible to receive SC infliximab 240 mg, double the approved maintenance dose, as a form of reintroduction.

The present post hoc analysis evaluated 51 CD and 77 UC patients from the placebo arms, assessing clinical, biochemical, endoscopic, and pharmacokinetic outcomes through week 102.

Early clinical responses emerged within 8 weeks of SC infliximab initiation and were sustained throughout the study period, with partial clinical response rates of 92.3% in CD and 96.6% in UC at treatment end. Fecal calprotectin remission was achieved in 61.1% of CD patients and 65.2% of UC patients, with endoscopic response rates of 64.0% and 68.8%, respectively. Additionally, treatment persistence through week 102 was 72.3% in CD and 61.9% in UC.

Dubinsky highlighted the parallel between clinical recapture and pharmacokinetic recovery as a key finding. Serum infliximab levels rose markedly after SC reintroduction and remained stable, a pattern that tracked directly with clinical response.

“You see this parallel where you get this recapturing in 8 weeks, and when you look at the trough level, you then see you've recaptured the trough level that you stay at throughout that period of you now being in the 240 arm,” she said. “I think the fact that you see that association of the PK coming back after no drug level, or a honeymoon during that period, and you see that clinical response parallel the recapture of the trough level, or that consistent, sustained drug level that we're used to, really tells you that you recapture because you're able to bring back the drug concentration that's associated with response.”

Dubinsky additionally highlighted immunogenicity findings as among the most clinically significant data from her research. Reintroduction of IV infliximab after a drug holiday carries well-documented risk of infusion reactions, driven by a surge in anti-drug antibodies (ADAs) upon re-exposure. SC reintroduction appeared to sidestep this problem. Despite high ADA rates at the time of SC reintroduction, antibody status had minimal impact on outcomes, with approximately three quarters of patients maintaining treatment persistence regardless of ADA status.

Dubinsky noted that SC infliximab 240 mg is not currently FDA-approved for this indication in the US, but expressed hope that publication of these data would support conversations with payers and health authorities about its clinical utility.

Editor's note: Dubinsky reports relevant disclosures with AbbVie, Abivax, Astra Zeneca, BMS, Celltrion, Eli Lilly, Janssen, Johnson and Johnson, Merck, Pfizer, Prometheus Labs, Roche, Sanofi, Spyre, Takeda, and others.

Dubinsky MC, Sands BE, Abraham BP, et al. Recapturing Disease Control With Subcutaneous Infliximab After a Drug Holiday Following Intravenous Infliximab Induction: A Post Hoc Analysis of LIBERTY-CD and -UC Studies. Presented at Digestive Disease Week (DDW) 2026; Chicago, IL; May 2–5, 2026.

Rubin DT. Restarting Biologic Agents After a Drug Holiday. 

Videos

Marla Dubinsky, MD, explains LIBERTY post hoc data showing SC infliximab 240 mg recaptured clinical response within 8 weeks in CD and UC patients following a drug holiday.

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Strategic Alliance Partnership

Subcutaneous Infliximab Recaptures Disease Control After Treatment Interruption in IBD

Laurie Keefer, PhD, is a clinical health psychologist and professor of medicine at Icahn School of Medicine at Mount Sinai.

The Brain-Gut Connection in GI Clinical Practice

The gut microbiome has become a fixture of consumer wellness culture, but for practicing gastroenterologists, the clinical reality of gut health is considerably more nuanced.

At Digestive Disease Week (DDW) 2026 in Chicago, IL, Laurie Keefer, PhD, a health psychologist and professor of medicine at the Icahn School of Medicine at Mount Sinai, led a session calling on clinicians to expand their framework for gut health, one that accounts for the psychosocial forces shaping their patients' lives and explicitly integrates mental health into GI care.

"Gut health is a hot topic right now," Keefer told 

. "If you go on TikTok, it means one thing. If you come to DDW, it means another."

The Social Determinants Shaping Gut Health

For clinicians, gut health encompasses far more than diet or supplement use. Keefer emphasized that the full range of social determinants and lifestyle factors, including chronic stress, physical inactivity, loneliness, and ongoing exposure to conflict and geopolitical instability, all influence the gut microbiome and contribute to dysbiosis. Research has increasingly linked social isolation and loneliness to reduced gut microbial diversity, itself associated with a range of inflammatory and cardiometabolic conditions.

"All of our patients should be concerned about their gut health, because they live in this world today," Keefer said.

The Bidirectional Mental Health Connection

A central theme of Keefer's session was the inseparability of gut health and mental health. The United States is in the midst of a recognized mental health crisis, and the gut-brain axis sits squarely at the intersection of these public health challenges. The microbiota-gut-brain axis is a complex, bidirectional communication network linking the central nervous system and the gastrointestinal tract, with growing evidence that gut health can impact mental well-being and vice versa. For clinicians, this means that anxiety and depression are not merely comorbidities to be managed separately, but rather act as active drivers of gut dysfunction, and gut dysfunction can perpetuate them.

"You can have depression and anxiety that affects your gut health, and your gut health can lead to depression and anxiety," Keefer explained. "We really can't disentangle those two things."

The third pillar of Keefer's session addressed the clinical role of brain-gut behavior therapies (BGBTs), a class of interventions that includes cognitive behavioral therapy, gut-directed hypnotherapy, and other psychologically informed approaches. These therapies target not only lifestyle and mental health, but also the way patients perceive and respond to GI symptoms.

BGBTs are short-term, clinician-administered interventions, and a 2025 systematic review and network meta-analysis published in 

 found that several, particularly those classified as brain-gut behavior therapies, are efficacious for global IBS symptoms.

Keefer framed this perceptual component as underappreciated in routine care. How a patient interprets mild bloating, and what behavioral response that triggers, can meaningfully shape the downstream course of their gut symptoms.

"We're targeting things like lifestyle and behaviors and mental health, but also the way symptoms are perceived," she said. "Really full circle, but not separating gut health from mental health."

Editors’ note: Keefer reports relevant disclosures with AbbVie, Ardelyx, Eli Lilly, Janssen, Pfizer, and others.

Keefer L. PSYCHOLOGICAL APPROACHES TO IMPROVE GUT HEALTH. Session presented at: Digestive Disease Week (DDW) 2026; Chicago, IL; May 2–5, 2026.

Culli L. Nearly 1 in 10 Adults in the U.S. Experienced a Mental Health Crisis Last Year. Johns Hopkins. August 19, 2025. Accessed May 3, 2026. 

https://publichealth.jhu.edu/2025/mental-health-crisis-hits-nearly-1-in-10-us-adults

Thakur ER, Khasawneh M, Moayyedi PM, et al. Efficacy of behavioural therapies for irritable bowel syndrome: a systematic review and network meta-analysis. The Lancet Gastroenterology & Hepatology. doi:

Laurie Keefer, PhD, makes the case for integrating mental health, social determinants, and brain-gut behavior therapies into routine GI care.

Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Rethinking Gut Health: Social Determinants, Mental Health, and Brain-Gut Therapies

Anjali Byale, MD, is a fellow at West Virginia University School of Medicine.

EUS-Guided Procedures vs Traditional Interventions for High Risk GI Patients

As endoscopic ultrasound (EUS)-guided procedures continue to gain traction in 

, a pair of new network meta-analyses presented at Digestive Disease Week (DDW) 2026 in Chicago, IL, offer the most comprehensive comparative data to date on their performance across key clinical outcomes.

Anjali Byale, MD, a gastroenterologist at West Virginia University, presented findings evaluating EUS-guided gallbladder drainage (EUS-GBD) for high-risk acute cholecystitis and direct EUS-guided gastroenterostomy (EUS-GE) for malignant gastric outlet obstruction (GOO), 2 conditions that have historically required surgical management.

"In the last 10 to 12 years, the trend has been more toward EUS-guided procedures," Byale told HCPLive. "These are procedures we can do on an outpatient basis — patients come in the morning and, if everything goes well, go home the same day."

EUS-GBD for High-Risk Acute Cholecystitis

The first study pooled data from 14 comparative studies published between 2012 and 2021, encompassing 1410 patients with a weighted mean age of 67.8 years. EUS-GBD was compared against laparoscopic cholecystectomy (LC), percutaneous gallbladder drainage (PC-GBD), endoscopic transpapillary gallbladder stenting (ETGS), and endoscopic naso-gallbladder drainage (EN-GBD).

Results showed EUS-GBD demonstrated superior clinical success compared with ETGS and was non-inferior to LC and PC-GBD. Technical success and adverse event rates were comparable across modalities. The most striking finding, however, was in reintervention: patients who underwent PC-GBD were nearly 9 times more likely to require reintervention than those who received EUS-GBD (odds ratio [OR], 8.76; 95% CI, 4.38-174.39).

"For someone who is a poor surgical candidate, we don't want to put them through anesthesia multiple times," Byale said. "Reintervention rates really matter, and EUS-GBD has a clear advantage there."

Direct EUS-GE for Malignant Gastric Outlet Obstruction

The second meta-analysis drew from 23 retrospective studies published between 2017 and 2025, totaling 2604 patients, comparing direct EUS-GE against enteral stenting (ES) and surgical gastrojejunostomy (SGJ) for malignant GOO.

Clinical success was comparable across all three modalities. However, SGJ carried significantly higher adverse event rates than EUS-GE (OR, 6.55; 95% CI, 3.38–12.69), and ES was associated with substantially higher reintervention rates (OR, 4.18; 95% CI, 1.60–10.90), largely driven by stent migration. While ES demonstrated the highest technical success, Byale cautioned against prioritizing that metric at the expense of durability and safety.

"We cannot compromise clinical success, that is the most important thing," she said. "But once procedures are comparable on that front, adverse events and reintervention become critical factors, especially for patients who are expected to live longer."

Institutional Capabilities and Patient Selection

Byale noted that EUS-guided procedures require advanced endoscopy expertise not available at all centers, and that LC, PC-GBD, and ES remain viable options where EUS capability is limited. The overarching message, she emphasized, is that clinical decision-making must weigh institutional resources, patient prognosis, and the full constellation of outcomes, not technical success alone.

Editors’ note: Byale reports no relevant disclosures.

Byale A, Adoor DM, Moond V, et al. EUS-GBD STRIKES THE OPTIMAL BALANCE OF SUCCESS, SAFETY, AND REINTERVENTION IN HIGH-RISK ACUTE CHOLECYSTITIS: A NETWORK META-ANALYSIS. Presented at Digestive Disease Week (DDW) 2026 in Chicago, IL, May 2-5, 2026.

Byale A, Adoor DM, Moond V, et al. DIRECT EUS-GE OUTPERFORMS ES AND SGJ IN SAFETY AND REINTERVENTION WHILE MATCHING CLINICAL SUCCESS: A 23-STUDY NETWORK META-ANALYSIS. Presented at Digestive Disease Week (DDW) 2026 in Chicago, IL, May 2-5, 2026.

Anjali Byale, MD, reviews data supporting EUS-guided procedures as first-line options for high-risk patients with cholecystitis or malignant gastric outlet obstruction.

EUS-Guided Procedures Outperform Traditional Interventions for High-Risk GI Patients

Sobia Laique, MD, is a gastroenterologist and transplant hepatologist at Cleveland Clinic.

Can Metabolic Surgery Reverse MASH Cirrhosis?

For decades, cirrhosis has been understood as an irreversible, fibrotic scar replacing functional liver tissue, largely viewed as an endpoint. However, emerging evidence is challenging that assumption, particularly in the setting of 

metabolic dysfunction-associated steatohepatitis (MASH)

New research presented by Sobia Laique, MD, a gastroenterologist and transplant hepatologist, Chair of the MASLD Task Force, and director of the Multidisciplinary MASLD Center at Cleveland Clinic, at Digestive Disease Week (DDW) 2026 in Chicago, IL, suggests that for select patients with compensated MASH cirrhosis, metabolic bariatric surgery may not only halt disease progression, but actually reverse it.

The research builds on previously published findings from the SPECIAL study, which demonstrated a 72% reduction in major adverse liver outcomes, including variceal hemorrhage, hepatic encephalopathy, liver cancer, need for transplant, and liver-related death, in patients with compensated MASH cirrhosis who underwent MBS.

"When we saw that, it begged the question: did we potentially also reverse the cirrhosis itself?" Laique told 

To explore that question, the team conducted a retrospective cohort study of 30 patients with biopsy-proven compensated MASH cirrhosis who underwent metabolic bariatric surgery between 2004 and 2024 at a single tertiary care center. All patients had F4 fibrosis on baseline biopsy, no prior decompensation or liver transplant, and a median biopsy interval of 6.2 years. The cohort was metabolically advanced, with a mean BMI of 43.7 kg/m² and 87% having diabetes, but carefully selected for compensated disease.

Laique noted that a key insight from the study was methodological: how cirrhosis regression is measured matters. Conventional staging systems, such as the NASH CRN scoring system, define regression as a transition from F4 to F3 or lower, capturing stage changes but potentially missing subtler architectural remodeling, such as thinning or fragmentation of fibrous septa that does not shift the overall stage. When the team applied more granular frameworks, including the Ishak and Beijing classifications, which specifically assess architectural changes within fibrotic tissue, regression rates were meaningfully higher.

Using conventional NASH CRN staging, approximately one-third of patients showed cirrhosis regression. With Ishak scoring, that figure rose to 40%, and with the Beijing classification, to 60%.

"Even if there's a 1-in-3 chance that I have the ability to reverse a patient's disease, that's something I would want to be able to offer them, let alone if that goes up to 40 or 60%," Laique said.

Beyond regression rates, the findings carry broader implications for clinical practice, according to Laique. First, metabolic bariatric surgery can now be positioned as a truly disease-modifying intervention for patients with compensated MASH cirrhosis, one capable of improving long-term outcomes and reversing underlying disease. Second, the field needs to reassess how it measures fibrosis regression, not only in the context of surgical intervention, but also as pharmacologic therapies continue to emerge.

Laique noted that next steps should include prospective studies comparing metabolic bariatric surgery with GLP-1 receptor agonists, as well as mechanistic investigations into what drives cirrhosis regression, work she says her team is actively pursuing at the Cleveland Clinic.

Editor's note: Laique reports no relevant disclosures.

 Long-term liver outcomes after metabolic surgery in compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis. 

https://doi.org/10.1038/s41591-024-03480-y

Laique S, Hammad AF, Allende DS, et al. CAN METABOLIC SURGERY REGRESS MASH CIRRHOSIS? EVIDENCE FROM PAIRED BIOPSIES. Presented at Digestive Disease Week (DDW) 2026 in Chicago, IL, May 2-5, 2026.

New paired biopsy data show histologic regression after metabolic bariatric surgery in compensated MASH patients, challenging the irreversibility of cirrhosis.

Hepatology

MASH / MASLD

The HCPLive MASH & MASLD page is a comprehensive resource for clinical news and insights on metabolic dysfunction-associated steatotic liver disease and steatohepatitis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for fatty liver disease, steatohepatitis, and more.

Histologic Evidence of MASH Cirrhosis Regression After Metabolic Bariatric Surgery, With Sobia Laique, MD

Allison Wu, MD, MPH, is a general pediatric gastroenterologist at Boston Children’s Hospital and an assistant professor of pediatrics at Harvard Medical School.

How Food Access Shapes Childhood Obesity Risk

 remains one of the most pressing public health challenges in the United States, with growing recognition that its roots extend far beyond individual behavior. Increasing attention is being turned to the broader food environment, both at the neighborhood and household levels, as a key driver of long-term health outcomes.

0:00:13 – Defining food access vs food availability

0:01:0 – Study design and main findings

0:02:40 – Critical windows for intervention

0:04:05 – Role of gastroenterologists and team-based care

0:05:15 – Policy and “food is medicine” advocacy

New research presented by Allison Wu, MD, MPH, a general pediatric gastroenterologist at Boston Children’s Hospital and an assistant professor of pediatrics at Harvard Medical School​, at Digestive Disease Week (DDW) 2026 offers important insight into how these factors intersect to shape obesity risk over time.

In a large retrospective cohort study of nearly 14,000 children aged 2 to 11 years across Mass General Brigham-affiliated sites, she and colleagues examined how neighborhood food access and household food security influence body mass index (BMI) trajectories and obesity risk. Using geocoded residential data linked to the USDA Food Access Research Atlas, the study identified children living in low-income, low-vehicle (LILV) neighborhoods, areas where access to supermarkets is limited.

Over a 5-year follow-up period spanning 2019 to 2024, residence in these neighborhoods was associated with significantly higher BMI z-scores and an increased risk of obesity.

Of note, these effects were not immediate but emerged over time. Children living in LILV neighborhoods had a nearly 2-fold increased risk of obesity by age 10 compared to peers in areas with better food access, even after adjusting for insurance status. Parallel findings were observed at the household level, where children from food-insecure households also demonstrated higher BMI trajectories and elevated obesity risk, reinforcing the independent and additive roles of these exposures.

The study also underscores the importance of timing in intervention strategies. While differences in BMI were not apparent in early childhood, disparities became significant later, particularly in older children and adolescents. This suggests that early life remains a critical window for prevention, even before measurable differences emerge.

“I think of the critical windows for intervention as 2-fold. One is in early childhood thinking of obesity prevention. Even though we didn't see these effects at age 5, obesity prevention needs to be an area of focus, so intervening early on in life,” Wu said. “I think of the first 1000 days of life as being an important period to prevent obesity and promote optimal health, and then later on, early adolescence is another critical window for intervention.”

For gastroenterologists, these findings carry direct clinical relevance. Specialists often encounter the downstream effects of obesity, including 

metabolic dysfunction-associated steatotic liver disease

. This positions them as important touchpoints for screening and intervention. However, Wu stressed that addressing food access challenges requires a team-based approach.

“Working with primary care physicians, working with our dietitians, social work, other patient health navigators, is critical because it does not by any means rely on the gastroenterologist alone, and we have found a team-based approach is what's most productive and collaborative in helping navigate healthy food access, at least in terms of children and for families,” she explained.

Looking ahead, the findings support a multilevel strategy to combat childhood obesity that integrates clinical screening with community-based interventions and policy-level changes. Expanding access to nutrition support programs, including “food is medicine” initiatives and Medicaid-covered services, may play a critical role in bridging gaps.

Editors’ note: Wu reports no relevant disclosures.

US Centers for Disease Control and Prevention. Childhood Obesity Facts. April 2, 2024. Accessed May 2, 2026. 

https://www.cdc.gov/obesity/childhood-obesity-facts/childhood-obesity-facts.html

Wu A, Arris IM, Luo M, et al. MULTILEVEL ASSOCIATIONS OF THE FOOD ENVIRONMENT WITH CHILD BODY MASS INDEX AND OBESITY. Presented at Digestive Disease Week (DDW) 2026 in Chicago, IL, May 2-5, 2026.

Wu describes her research linking low food access and food insecurity to higher childhood obesity risk, highlighting the need for early, multilevel prevention strategies.

Obesity Management

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Why Food Access Matters in Childhood Obesity Prevention, With Allison Wu, MD, MPH

Basile Njei, MD, PhD, MPH, is an assistant professor at Yale School of Medicine.

Njei explains the evolving treatment landscape for MASLD and how it impacts the cost-effectiveness of noninvasive tests for screening.

Optimizing MASLD Screening in the Era of Liver-Directed Therapy, With Basile Njei, MD, PhD, MPH

Articles

Stay updated with the latest healthcare breakthroughs, including notable FDA approvals and filings, in this week’s essential news roundup.

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The HCPFive: Top News for Healthcare Providers from the Week of 04/26

Jignesh Shah, MD, is a gastroenterologist at Gastroenterology Consultants, PA.

Shah describes the science and real-world use of gluten sensors, with insights on how these tools may support patients with celiac disease without replacing standard care.

The Emerging Role of Gluten Detection Sensors in Celiac Disease Care, With Jignesh Shah, MD

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

This iteration of the ‘Month in Review’ series highlights top headlines covered in April in dermatology news, including FDA decisions.

Dermatology

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7 Dermatology Headlines You Missed in April 2026

Elizabeth Kiracofe, MD, speaks in this segment of her recent The Medical Sisterhood podcast about her career and other community initiatives.

Getting Involved in the Community as a Dermatologist, With Elizabeth Kiracofe, MD

Rachael Sood, NP, is a diabetes nurse practitioner and Owner and CEO of The Diabetes Collective.

Sood shares her thoughts on the recent announcement by the FDA, limiting pharmacies’ ability to compound semaglutide, tirzepatide, and liraglutide from bulk substances.

FDA News

Type 2 Diabetes

FDA Proposes Exclusion of Multiple GLP-1 RAs from Bulks List, With Raechel Sood, NP

Pranav Garimella, MBBS, MPH, is chief medical officer of the American Kidney Fund.

APOL1 research is driving precision nephrology, but prediction gaps and equity challenges still limit clinical impact.

Nephrology

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APOL1-Mediated Kidney Disease: From Genetic Discovery to the Edge of Precision Medicine

Physician and CEO, Chicago Allergy Center, and board director at American Lung Association

The first single-inhaler ICS/LABA/LAMA combination for asthma adds a mechanistically distinct bronchodilator to a well-established inhaled backbone.

BGF Triple Therapy FDA Approval Expands Asthma Options for Underserved Patients, With Juanita Mora, MD

Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

FDA expands lumateperone for relapse prevention in schizophrenia, White House boosts psychedelics research, and AI reshapes psychiatry care debates in April 2026.

Major Depressive Disorder

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5 Psychiatry Headlines You Missed in April 2026

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.

April 2026 saw new data from pivotal clinical trials and a new approval in asthma.

Asthma

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Latest News

Subcutaneous Infliximab Recaptures Disease Control After Treatment Interruption in IBD

Rethinking Gut Health: Social Determinants, Mental Health, and Brain-Gut Therapies

EUS-Guided Procedures Outperform Traditional Interventions for High-Risk GI Patients

Histologic Evidence of MASH Cirrhosis Regression After Metabolic Bariatric Surgery, With Sobia Laique, MD

Why Food Access Matters in Childhood Obesity Prevention, With Allison Wu, MD, MPH