Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Jessica Castle, MD, is the vice president of medical affairs at Dexcom.

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!

Diabetes Dialogue: The G7 15-Day System and CGM Innovations at Dexcom, With Jessica Castle, MD

In this episode of Diabetes Dialogue, host Diana Isaacs, PharmD, is joined by Jessica Castle, MD, vice president of medical affairs at Dexcom, to discuss the company’s recent innovations in continuous glucose monitoring (CGM) and their clinical implications.

To open the episode, Castle outlines the launch of the Dexcom G7 15-day system, highlighting its extended wear duration, improved accuracy (MARD ~8%), and strong early adoption among adults. She notes ongoing efforts to optimize sensor longevity, particularly through adhesive enhancements, while acknowledging that pediatric expansion remains under evaluation due to unique wear challenges in children. Integration with automated insulin delivery systems continues to evolve, with further updates anticipated.

The discussion then shifts to Dexcom’s newly cleared Smart Basal feature, designed to address persistent clinical inertia in basal insulin titration for type 2 diabetes. Castle explains how clinician-defined parameters within the Dexcom Clarity platform enable automated daily dose adjustments based on CGM data, with the goal of minimizing both hyperglycemia and hypoglycemia. Early data presented at ATTD demonstrate significant improvements in mean glucose (>40 mg/dL reduction) and time in range (>20 percentage point increase), without increased hypoglycemia, underscoring both the safety and efficacy of this approach.

Isaacs and Castle also explore recent advancements in Dexcom’s digital ecosystem, including AI-driven meal detection and nutritional analysis within the Stelo and G7 platforms. These tools facilitate real-time behavioral insights, reinforcing CGM’s role as a powerful driver of lifestyle modification. Castle emphasizes the growing integration of artificial intelligence to deliver actionable, personalized feedback while maintaining clinical reliability.

Expanding beyond glycemic metrics, Castle reviews emerging real-world evidence supporting CGM use across diverse populations. Retrospective analyses presented at ATTD demonstrate substantial reductions in diabetic ketoacidosis (DKA), including >90% risk reduction in pediatric 

 following CGM initiation. Additional registry data in non-insulin-treated type 2 diabetes show meaningful A1C reductions (~0.6%) and associated weight loss, reinforcing the value of CGM beyond insulin-dependent populations. The conversation also highlights complementary benefits when CGM is used alongside newer pharmacotherapies, including GLP-1 receptor agonists and dual incretin agents.

The episode further addresses gaps in evidence, particularly in pregnancy. While CGM adoption is increasing and supported by growing data in gestational diabetes, Castle acknowledges limited evidence in preexisting type 2 diabetes during pregnancy. Ongoing studies, including the IMAGINE trial, aim to evaluate earlier CGM implementation and its potential to improve maternal and fetal outcomes, potentially reshaping current screening paradigms.

The discussion concludes with a forward-looking perspective on Dexcom’s innovation pipeline. Castle highlights Smart Basal and the G7 15-day system as near-term practice-changing tools, alongside continued advancements in sensor design, accuracy, and usability. Both speakers emphasize the expanding role of CGM as a foundational technology in diabetes management, supporting a more proactive, data-driven, and patient-centered approach to care across clinical settings.

Editor’s Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others.

Podcasts

Jessica Castle, MD, joins the show to give a peek behind the curtain at Dexcom’s latest advancements in CGM technology.

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Type 1 Diabetes

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Diabetes Dialogue

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a monthly podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP, aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care.

Strategic Alliance Partnership

Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

March brought a steady stream of clinically significant updates in gastroenterology, spanning advances in inflammatory bowel disease (IBD), colorectal cancer screening, hepatic encephalopathy guidance, and persistent diagnostic challenges in everyday practice. From new clinical trial data to updated guideline recommendations, the month reflected both meaningful progress and ongoing gaps across the GI landscape.

New data from the AFFIRM trial highlighted the potential of subcutaneous risankizumab induction in Crohn’s disease, signaling a possible shift toward more flexible treatment approaches. At the same time, Colorectal Cancer Awareness Month placed renewed focus on screening, where, despite clear benefits and multiple available modalities, uptake continues to fall short of national goals.

The month also underscored the importance of clinical nuance, with expert insights into often-overlooked conditions like exocrine pancreatic insufficiency (EPI) and evolving strategies to reduce Clostridioides difficile recurrence. In parallel, updated guidance on hepatic encephalopathy offered clinicians a comprehensive framework for diagnosis and management.

Here’s a look at 5 key gastroenterology headlines from March 2026 you may have missed:

AFFIRM: Risankizumab (Skyrizi) Subcutaneous Induction Achieves Primary Endpoints in Crohn’s Disease

On March 2, 2026, AbbVie announced positive topline results from the phase 3, randomized, placebo-controlled, double-blind AFFIRM study evaluating the efficacy and safety of risankizumab (Skyrizi) subcutaneous (SC) induction treatment versus placebo in adult patients with moderately to severely active Crohn's disease (CD). Study findings showed significantly greater proportions of patients treated with risankizumab SC induction achieved the co-primary endpoints of Crohn's Disease Activity Index (CDAI) clinical remission and endoscopic response at week 12 compared to placebo. Of note, among patients with clinical response after 12 weeks of risankizumab SC induction treatment followed by 12 weeks of maintenance, 67% achieved CDAI clinical remission at week 24 and 57% achieved endoscopic response at week 24.

Risankizumab Subcutaneous Induction for Crohn’s Disease: Insights From the AFFIRM Trial, With Millie Long, MD, MPH

Can Crohn’s Induction Move Beyond Infusions? AFFIRM Trial Insights

Colorectal Cancer Screening in 2026: Progress, Gaps, and What Comes Next, With Renee Williams, MD

Despite decades of public health messaging and clear evidence supporting the benefits of screening, colorectal cancer screening rates in the United States remain below national targets. During the month of March, recognized as Colorectal Cancer Awareness Month, gastroenterologists emphasize both the progress made and the work that still lies ahead to improve early detection of colorectal cancer. Renee Williams, MD, explains the different colorectal cancer screening options available to patients, persistent barriers to uptake, and strategies to improve screening rates.

Colorectal Cancer Screening Explained: Colonoscopy, FIT, and What Comes Next

Diagnostic Challenges and Clinical Nuance of EPI, With Adam Kichler, DO

Greasy, foul-smelling stools and persistent bloating are often dismissed as routine gastrointestinal complaints, but they can signal a more overlooked issue. EPI remains a frequently missed contributor to gastrointestinal symptom burden, in part because its clinical presentation so often overlaps with more commonly diagnosed conditions. Adam Kichler, DO, a gastroenterologist and advanced endoscopist at Allegheny Health Network, explained why EPI is frequently overlooked in patients with symptoms resembling IBD or celiac disease and offered key insights on diagnosis and management.

Bridging the Gap in EPI Diagnosis and Management

ACG Issues New Hepatic Encephalopathy Guidelines For Diagnosis, Treatment, Nutrition, and Transplant, With Jasmohan Bajaj, MD, MS

A new American College of Gastroenterology guideline outlines 24 recommendations for the diagnosis, management, and prevention strategies for hepatic encephalopathy. Jasmohan Bajaj, MD, breaks down the key points from the document and what they mean for practice.

Vancomycin Taper Strategies to Prevent C Difficile Recurrence, With Emily McDonald, MD, MSc

 infection (CDI) affects an estimated 450,000 patients annually in the United States and carries substantial morbidity and healthcare costs. According to the US Centers for Disease Control and Prevention, about 1 in 9 people who get CDI will get it again in the subsequent 2-8 weeks. Emily McDonald, MD, MSc, explains the potential of an initial vancomycin taper regimen after standard therapy for reducing these recurrences.

Catch up on new IBD drug trial data, updated HE guidelines from the American College of Gastroenterology, and more.

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Exocrine Pancreatic Insufficiency

The HCPLive Exocrine Pancreatic Insufficiency page is a comprehensive resource for clinical news and insights on exocrine pancreatic insufficiency. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies.

Inflammatory Bowel Disease

On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

5 Gastroenterology Headlines You Missed in March 2026

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.

March 2026 featured a range of developments across psychiatry, including emerging psychedelic therapies, accelerated neuromodulation strategies, ethical considerations around artificial intelligence in mental health care, and new observational data linking metabolic therapies to psychiatric outcomes.

This month in review features the top 6 headlines in psychiatry.

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

Growing patient use of generative artificial intelligence tools for mental health support prompted discussion among psychiatrists and ethicists regarding safety, oversight, and clinical integration. Experts emphasized that patients are increasingly turning to conversational AI platforms for therapy-like interactions, raising concerns about accuracy, crisis management, and therapeutic boundaries. Clinicians highlighted the need for guidance on how to counsel patients using these tools, while acknowledging potential benefits such as increased accessibility and stigma reduction.

The discussion underscored that AI-based support may complement, but not replace, clinician-delivered psychotherapy, particularly for patients with complex psychiatric conditions or suicide risk.

 Richard Miller, MD (Elwyn Adult Behavioral Health), Hans Eriksson, MD, PhD (HMNC Brain Health), and Darlene King, MD (University of Texas Southwest Medical Center).

Latest Psychedelic Research in Depression

Single-Day GH001 for TRD Shows Rapid Response, With Michael E. Thase, PhD

A phase 2b trial of inhaled mebufotenin (GH001) demonstrated rapid and clinically meaningful improvement in treatment-resistant depression (TRD) following a single-day individualized dosing regimen. Participants received up to 3 escalating doses within 1 treatment session, with symptom improvements observed within 1 week.

In a randomized cohort, remission by day 8 occurred in 57.5% of treated patients compared with none receiving placebo, with a large effect size and rapid onset of benefit. Investigators highlighted the potential scalability of a single-day psychedelic-based intervention relative to multi-session treatment models.

Psychedelic Therapy Matches Efficacy of Antidepressants in MDD, With Balázs Szigeti, PhD

A meta-analysis evaluating psychedelic-assisted therapy versus antidepressants in major depressive disorder (MDD) found comparable symptom improvement when accounting for trial blinding differences. Investigators noted that psychedelic-assisted therapy produced robust antidepressant effects but did not demonstrate superiority over open-label antidepressant treatment.

The findings suggested psychedelic therapy may expand treatment options rather than replace established pharmacotherapy, with further research needed to assess functional outcomes and real-world implementation.

Accelerated Deep TMS Matches Standard Outcomes in TRD in 6 Days

Accelerated deep transcranial magnetic stimulation (dTMS) delivered over 6 days produced clinical outcomes comparable to standard multiweek treatment in MDD. A multisite noninferiority trial showed similar response and remission rates while shortening treatment duration.

Accelerated protocols also demonstrated faster symptom improvement and reduced time to remission, supporting their potential to improve access and adherence among patients with treatment-resistant depression.

Accelerated rTMS Matches Conventional Protocol in TRD, With Andrew Leuchter, MD

Separate data comparing accelerated repetitive TMS (rTMS) to conventional once-daily treatment found both approaches produced significant reductions in depressive symptoms, with no statistically significant difference in efficacy.

Investigators noted that compressing treatment into a single week may improve adherence and reduce disruption to daily functioning, offering practical advantages for patients and clinics.

Semaglutide Linked to Lower Suicidality Risk in Diabetes, With Mark Taylor, MD

Real-world registry data suggested glucagon-like peptide-1 receptor agonists, including semaglutide, were associated with reduced suicidality, anxiety, and psychiatric-related sick leave among patients with type 2 diabetes. Investigators used a within-individual design comparing treatment and non-treatment periods for the same patients, strengthening causal inference.

The findings counter earlier safety concerns and highlight potential mental health benefits of metabolic therapies, although experts emphasized these agents should not be considered primary psychiatric treatments.

Articles

March 2026 psychiatry updates spanned AI-enabled mental health support, psychedelic interventions for depression, accelerated neuromodulation, and metabolic therapy–psychiatric outcome links. Clinicians and ethicists raised concerns about generative AI accuracy, crisis handling, and boundary-setting, while positioning AI as adjunctive rather than substitutive care. Psychedelic data included rapid TRD response to single-day inhaled mebufotenin and meta-analytic evidence suggesting efficacy comparable to antidepressants when blinding is considered. Noninferiority trials supported 1-week accelerated TMS protocols. Registry analyses associated GLP-1 receptor agonists with lower suicidality signals.

Rapid psychedelic therapies, accelerated TMS protocols, AI-driven care debates, and semaglutide’s link to reduced suicidality shaped psychiatry headlines in March 2026.

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.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

6 Psychiatry Headlines You Missed in March 2026 

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

American College of Cardiology (ACC) Scientific Sessions 2026

 saw the presentation of a slew of major, practice-changing studies and trials. Between fractional flow reserve (FFR) angiography in patients with coronary artery disease (CAD) from the ALL-RISE trial to mavacamten’s positive efficacy data in adolescent patients with 

obstructive hypertrophic cardiomyopathy (oHCM)

, major data was presented for just about every major disease state in cardiology.

In light of the sheer volume of new research, the editorial team at 

 has collected 6 of the most practice-changing results from ACC.26. Catch up on any major study data you may have missed during the conference below:


FFR Angiography Noninferior to Pressure-Wire Strategy in CAD Analysis, With William Fearon, MD


Presented by William Fearon, MD, professor of medicine and director of interventional cardiology at Stanford, the ALL-RISE study proved the noninferiority of angiography-guided FFR compared to a pressure-wire-guided strategy in patients with CAD. Enrolling a total of 1930 patients, the trial demonstrated a 98.5% success rate for FFR angiography compared to a 98.6% success rate for pressure-wire-based measurements. The mean time to calculate the assessment was 6 minutes in the FFRangio group and 8 in the pressure-wire group.


SCOUT-HCM: Mavacamten Outperforms Placebo in Adolescents With HCM, With Joseph Rossano, MD, MS


Mavacamten successfully demonstrated greater reductions in left ventricular outflow compared to placebo in adolescent patients with oHCM in the SCOUT-HCM trial. Joseph Rossano, MD, MS, co-director of the Cardiac Center at the Children’s Hospital of Philadelphia, presented the data at ACC.26, demonstrating the drug’s efficacy among 44 patients. Mean Valsalva left ventricular outflow tract gradient ultimately decreased by 48.5 mmHg in the mavacamten arm compared to -0.5 mmHg in the placebo arm, and Rossano and colleagues ultimately reported few significant adverse events.


Ultrasound-Facilitated Catheter-Directed Fibrinolysis Reduces Early Decompensation in Pulmonary Embolism


The HI-PEITHO study, investigating ultrasound-facilitated, catheter-directed fibrinolysis with anticoagulation in patients with acute, intermediate-risk pulmonary embolism (PE), has demonstrated the system’s superiority to anticoagulation alone. Among 544 patients, this catheter intervention substantially reduced the risk of early clinical deterioration – a combination outcome of incidence of PE-related death, cardiorespiratory decompensation or collapse, and symptomatic PE recurrence within 7 days occurred in 11 patients in the intervention arm compared to 28 in the control group.


CHAMPION-AF: Left Atrial Appendage Closure Noninferior to NOACs


The CHAMPION-AF trial demonstrated the noninferiority of device-based left atrial appendage closure (LAAC) compared to non-vitamin K antagonist oral anticoagulant (NOAC) therapy in preventing adverse events in patients with 

. The trial enrolled 3000 patients with non-valvular AF at elevated stroke risk, who were then randomized to either the Watchman FIx device or an approved NOAC. Ultimately, a composite primary efficacy endpoint cardiovascular death, stroke, or systemic embolism occurred in 81 patients among the device group and 65 in the NOAC group, resulting in a difference of 0.9 percentage points.


Don't Miss a Beat: MRA Updates at ACC 2026 Scientific Sessions


SPIRIT-HF ultimately showed that spironolactone did not significantly reduce a composite endpoint of 

 hospitalization and cardiovascular death compared to placebo in patients with heart failure with preserved ejection fraction (HFpEF) or mildly reduced ejection fraction (HFmrEF). In actuality, patients administered spironolactone saw an increase in hospitalizations and severe adverse events, potentially raising questions about the safety of the drug in HFpEF and HFmrEF. However, investigators noted high discontinuation due to the COVID-19 pandemic, potentially influencing the study’s capacity to conclusively demonstrate differences between the groups.


IVUS-CHIP: IVUS-Guided PCI Fails to Demonstrate Superiority in Complex Coronary Arteries

Among 2020 patients with complex coronary arteries, randomly assigned in a 1:1 ratio to either IVUS-guided PCI or angiography-guided PCI, target-vessel failure occurred in 14% of patients in the IVUS arm compared to 11% in the angiography arm. The trial failed to demonstrate IVUS-guided PCI’s superiority to angiography, with complications occurring in 11.3% of the IVUS group and 10.2% of the angiography group. Investigators ultimately declared that the industry is not currently capable of leveraging intravascular imaging data to guide PCI in a manner that justifies the increased complexity and cost of the procedure.

ACC.26 highlighted several potentially practice-shaping datasets spanning CAD physiology, structural interventions, PE, HCM, and HF. Angiography-derived FFR achieved noninferior procedural success versus pressure-wire assessment with faster computation. In adolescents with obstructive HCM, mavacamten produced marked LVOT gradient reductions with few major safety signals. For intermediate-risk PE, ultrasound-facilitated catheter-directed fibrinolysis reduced early clinical deterioration versus anticoagulation alone. LAAC with Watchman FLX was noninferior to NOACs for composite thromboembolic outcomes. Conversely, spironolactone disappointed in HFpEF/HFmrEF, and IVUS-guided PCI did not outperform angiography.

Catch up on data from some of the most impactful trials presented at the American College of Cardiology 2026.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

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Cardiomyopathy

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ACC.26 Recap: 6 Practice-Changing Trials to Know

The first quarter of 2026 brought a series of notable US Food and Drug Administration (FDA) approvals, highlighting continued momentum in innovation across diverse therapeutic areas, including rare diseases, endocrinology, dermatology, psychiatry, and hepatology. A recurring theme was the expansion of treatment options for underserved populations, particularly pediatric and rare disease communities, alongside a growing emphasis on more convenient, patient-centered care.

Several decisions marked important firsts, including the first approved therapies for conditions like pediatric acquired thrombotic thrombocytopenic purpura (aTTP), cerebral folate deficiency, and acquired hypothalamic obesity. The FDA also advanced novel therapeutic approaches, with approvals introducing new mechanisms and classes, as well as first-in-indication treatments poised to reshape care in areas like psoriasis and cholestatic pruritus in primary biliary cholangitis (PBC).

At the same time, the quarter reflected ongoing progress in optimizing existing therapies, with higher-dose options, new pediatric indications, and innovations in drug delivery aimed at improving adherence and quality of life.

Check out this Q1 2026 FDA news month in review for a recap of HCPLive’s coverage of the top FDA approvals and research from the past few months:

FDA Approves Caplacizumab-yhdp (Cablivi) as First Pediatric aTTP Therapy

: Pediatric patients ≥ 12 years of age with aTTP in combination with plasma exchange and immunosuppressive therapy

: Approval supported by efficacy data from a retrospective chart review study of 30 patients 2-18 years of age showing 80% of patients achieved clinical remission. Builds upon caplacizumab’s initial 2019 approval for adults with aTTP and makes caplacizumab the first treatment for pediatric aTTP.

FDA Approves ProlivRx, First At-Home Neuromodulation Device for MDD

: Adults with major depressive disorder (MDD) who did not respond to ≥ 1 antidepressant

: Supported by clinical evidence from the MOOD Study, a randomized, controlled, multicenter clinical trial, evaluating Proliv Rx in MDD with inadequate response to antidepressant medications.

FDA Approves First Dual-Agent Eye Drop for Near Vision Loss

: Supported by results from a pair of pivotal phase 3 trials, BRIO I and BRIO II, conducted in adults with presbyopia. Represents the first regulatory authorization of a fixed-dose, dual-agent topical therapy for age-related near vision degradation.

FDA Approves ET-600 Desmopressin Acetate (Desmoda) for Central Diabetes Insipidus

: Central diabetes insipidus in pediatric patients

: Marks the first and only FDA-approved oral liquid formulation of desmopressin

FDA Approves 3 New Pediatric Indications for Once-Weekly Somapacitan-beco (Sogroya)

: Children ≥ 2.5 years of age with Idiopathic Short Stature (ISS), short stature born Small for Gestational Age (SGA) and with no catch-up growth by 2 years of age, or growth failure associated with Noonan Syndrome (NS)

: Supported by data from the REAL8 study as part of the ongoing REAL clinical trial program.

FDA Grants Accelerated Approval to Navepegritide for Achondroplasia in Children Aged 2 Years and Older

: Children ≥ 2 years of age with achondroplasia and open epiphyses

: Based on improvements in annualized growth velocity (AGV) from 3 phase 3 trials, with continued approval contingent on confirmatory evidence of clinical benefit

FDA Approves Leucovorin Calcium (Wellcovorin) Tablets as First Cerebral Folate Deficiency Treatment

: Adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1)

: Based on a systematic review of the published literature on the topic, including published case reports with patient-level information, as well as mechanistic data

FDA Approves Secukinumab for Pediatric Patients 12 Years and Older with HS

: Moderate to severe hidradenitis suppurativa (HS) in pediatric patients ≥ 12 years of age

: Approval makes it the only IL-17A inhibitor for this population, adding a differentiated biologic option to an area where treatment choices for younger patients have historically been limited

Icotrokinra, an Oral Il-23 Inhibitor, Receives FDA Approval for Psoriasis

: Moderate to severe plaque psoriasis in adults and pediatric patients ≥ 12 years of age weighing ≥ 40 kg who are candidates for systemic therapy or phototherapy

: Marks the first for an oral targeted peptide selectively blocking the IL-23 receptor and introduces a new mechanistic class to the psoriasis treatment landscape backed by data from multiple trials in the phase 3 ICONIC program

FDA Approves Higher Dose Semaglutide (Wegovy HD) Injection 7.2 mg for Obesity

: To be used along with a reduced calorie diet and increased physical activity to help adults with obesity lose weight and keep it off, provided they have tolerated the 2.4 mg dosage for ≥ 4 weeks and additional weight reduction is clinically indicated

: Based on results from the STEP UP trial program, a phase 3b 72-week randomized, double-blinded, placebo-controlled and active-controlled superiority trial designed to evaluate the efficacy and safety of semaglutide injection 7.2 mg compared to semaglutide injection 2.4 mg and placebo as an adjunct to lifestyle intervention.

FDA Approves Linerixibat (Lynavoy) As First Treatment for Cholestatic Pruritus in PBC

: Cholestatic pruritus in adult patients with PBC

: Approval makes it the first medicine approved in the US for this indication, supported by data from the global phase 3 GLISTEN trial, which met both primary and key secondary endpoints, demonstrating significant, rapid and sustained improvements in cholestatic pruritus and itch-related sleep interference versus placebo

FDA Approves Setmelanotide (Imcivree) for Acquired Hypothalamic Obesity

: Acquired hypothalamic obesity in adults and pediatric patients ≥ 4 years of age

: Approval makes it the first and only FDA-approved therapy for this condition, based on data from the global, randomized, double-blind, placebo-controlled phase 3 TRANSCEND trial

FDA Approves Insulin Icodec (Awiqli) as First Once-Weekly Basal Insulin for Type 2 Diabetes

: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes

: Makes it the first and only once-weekly basal insulin available in the US, based on results from the ONWARDS type 2 diabetes phase 3a program, which comprised 5 randomized, active-controlled, treat-to-target clinical trials in approximately 4000 adults with type 2 diabetes.

Q1 2026 FDA actions underscored sustained innovation across rare disease, endocrinology, dermatology, psychiatry, hepatology, and ophthalmology, with multiple first-in-indication approvals. Several decisions expanded pediatric access, including first therapies for pediatric aTTP and cerebral folate deficiency, and new pediatric indications in growth disorders and hidradenitis suppurativa. Patient-centric care advances included at-home neuromodulation for antidepressant-resistant MDD, an oral liquid desmopressin formulation, and once-weekly agents for diabetes and growth hormone deficiency.

A look at 13 key FDA approvals from Q1 2026, highlighting advances in rare disease, pediatrics, novel therapies, and patient-centered innovation.

FDA News

Hepatology

Obesity Management

Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

Dermatology

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.

Q1 2026 Recap: Top FDA Approvals

Catch up on the hematology headlines you missed in March 2026. 

Hematology

4 Hematology Headlines You Missed In March 2026

Amgen has announced positive topline results from their phase 3 trial comparing teprotumumab-trbw – administered via an on-body injector – to placebo.

News Report

Ophthalmology

Ophthalmology page, resources on the topics of medical news and expert insight into ophthalmic disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on eye disease research, treatment, and drug development.

Thyroid Disorders

Tepezza OBI Achieves Proptosis Reduction in Thyroid Eye Disease in Phase 3 Trial

Jane M. Grant-Kels, MD, is the vice chair of the Department of Dermatology and founding director of the Cutaneous Oncology Center and Melanoma Programs and a professor of dermatology, pathology, and pediatrics at the University of Connecticut Health Center.

This Q&A interview at AAD 2026 highlights health information technologies and AI tools used in dermatology practices.

Tips for AI and Health Information Technology in Dermatology Practice, With Jane M. Grant-Kels, MD

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

In this episode, "Value of Utilizing Matching-Adjusted Indirect Comparisons (MAICs) in Psoriasis," the expert dermatologists explore the methodology behind matching adjusted indirect comparisons and their practical value in guiding evidence based treatment decisions for plaque psoriasis.

Video Series

Value of Utilizing Matching-Adjusted Indirect Comparisons (MAICs) in Psoriasis

This episode, titled "Analyzing IL-23 Inhibitors in Psoriasis," features panelists discussing the future of IL-23 targeted therapies and the practical considerations surrounding the anticipated shift toward oral treatment options in plaque psoriasis.

Analyzing IL-23 Inhibitors in Psoriasis

Stay updated with the latest healthcare breakthroughs, including FDA actions and comparative weight loss drug data, in this week’s essential news roundup.

The HCPFive: Top News for Healthcare Providers from the Week of 03/29

This Q&A interview with Grant-Kels highlights takeaways from her session on managing the needs of patients in dermatology practicers who are pregnant.

Advice for Evaluating Pregnant Patients in Dermatology, With Jane M. Grant-Kels, MD

This episode covers the March 26th approval of Awiqli for T2D, highlighting its high concentration and once-weekly administration.

Type 2 Diabetes

Diabetes Dialogue: FDA Approves Novo Nordisk’s Insulin Icodec-abae (Awiqli) for T2D

Mardi Gomberg-Maitland, MD, MSc, is the director of the pulmonary hypertension program, chief clinical research officer at the Office of Clinical Research SMHS, and a professor of medicine at George Washington University.

Gomberg-Maitland addresses sotatercept’s capacity to improve pulmonary vascular and cardiac endpoints in patients with CpcPH-HFpEF.

CADENCE: Sotatercept Reduces PVR in CpcPH-HFpEF, With Mardi Gomberg-Maitland, MD, MSc

Sayna Norouzi, MD, is an assistant professor of medicine and clinical nephrologist at Loma Linda University Medical Center

Norouzi discussed the remaining challenges that come with having evolving treatment options and a robust patient population in IgAN.

Latest News

Diabetes Dialogue: The G7 15-Day System and CGM Innovations at Dexcom, With Jessica Castle, MD

5 Gastroenterology Headlines You Missed in March 2026

6 Psychiatry Headlines You Missed in March 2026

ACC.26 Recap: 6 Practice-Changing Trials to Know

Q1 2026 Recap: Top FDA Approvals