Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

Welcome back to our recap of this month's news and updates from the 

December 2025 was a landmark month for FDA approvals across rare diseases, hematology, pulmonology, cardiology, and metabolic disorders. Key approvals included first-in-class cellular and gene therapies: omidubicel-onlv for severe aplastic anemia and etuvetidigene autotemcel for Wiskott-Aldrich syndrome, both offering transplant-based options for patients without matched donors. Pediatric care advanced with berotralstat oral granules for children 2–11 years with hereditary angioedema, and narsoplimab for TA-TMA in patients aged ≥2 years, while mitapivat (AQVESME) addressed anemia in alpha- and beta-thalassemia, spanning transfusion-dependent and non–transfusion-dependent populations.

Other notable approvals expanded options for chronic and progressive diseases: inebilizumab-cdon for generalized myasthenia gravis, depemokimab-ulaa for severe eosinophilic asthma, nerandomilast for progressive pulmonary fibrosis, and aficamten for symptomatic obstructive hypertrophic cardiomyopathy, the latter with a REMS program due to heart failure risk. Metabolic disease management was transformed with the FDA’s approval of the first oral GLP-1 therapy for obesity, semaglutide (Wegovy), demonstrating robust weight loss in adults. Here’s a concise overview of the key FDA decisions and updates from December 2025.

Want to hear from the experts? Look for our Related Content links underneath blurbs for insight into how this decision might influence practice moving forward.

1. FDA Approves Omidubicel-onlv (Omisirge) As First Cellular Severe Aplastic Anemia Therapy

On December 8, 2025, the FDA approved omidubicel-onlv as the first hematopoietic stem cell transplant therapy for patients with severe aplastic anemia who lack a compatible donor. The approval of the nicotinamide-enhanced cord blood therapy was supported by clinical trial data showing rapid neutrophil recovery, high transfusion independence, and low rates of graft-versus-host disease.

2. FDA Approves Etuvetidigene Autotemcel (Waskyra) For Wiskott-Aldrich Syndrome

On December 9, 2025, the FDA approved etuvetidigene autotemcel as the first cell-based gene therapy for Wiskott-Aldrich syndrome, offering a new option for pediatric and adult patients without a suitable matched donor for transplantation. Supported by clinical studies and expanded access data, the therapy demonstrated sustained reductions in severe infections and bleeding events by correcting the underlying genetic defect using a patient’s own modified stem cells.

3. FDA Approves Oral Berotralstat for Children Aged 2 – 11 Years with HAE

On December 12, 2025, the FDA approved berotralstat oral granules for the prevention of hereditary angioedema attacks in children aged 2–11 years, expanding access to the first oral prophylactic therapy for this population. Supported by interim data from the APeX-P trial, the approval addresses a longstanding gap in pediatric HAE care by offering a less burdensome, once-daily option with sustained reductions in attack rates. The decision extends the role of oral prophylaxis to younger patients who previously relied largely on injectable or infusion-based therapies.

4. FDA Approves Inebilizumab-cdon (Uplizna) for Generalized Myasthenia Gravis

On December 11, 2025, the FDA approved inebilizumab-cdon for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-AChR or anti-MuSK antibody positive, expanding treatment options with a targeted therapy. Supported by data from the phase 3 MINT trial, the CD19-targeting monoclonal antibody demonstrated durable improvements in disease activity with a twice-yearly maintenance dosing schedule following initial loading.

5. FDA Approves Depemokimab-ulaa (Exdensur) for Severe Asthma

On December 16, 2025, the FDA approved depemokimab-ulaa as an add-on maintenance therapy for adults and adolescents aged 12 years and older with severe eosinophilic asthma. Supported by the phase 3 SWIFT-1 and SWIFT-2 trials, the ultra-long-acting biologic significantly reduced asthma exacerbations with just 2 doses per year, offering a lower-burden option compared with existing biologics. 

6. FDA Approves Nerandomilast (Jascayd) Tablets for Progressive Pulmonary Fibrosis

On December 19, 2025, Boehringer Ingelheim announced FDA approval of nerandomilast (Jascayd) tablets for the treatment of progressive pulmonary fibrosis (PPF) in adults. Based on results from the phase 3 FIBRONEER-ILD trial—the largest clinical trial program conducted in PPF to date—the preferential PDE4B inhibitor significantly reduced the rate of lung function decline, as measured by forced vital capacity, compared with placebo over 52 weeks and is now the first and only PDE4B inhibitor with immunomodulatory and antifibrotic activity approved for PPF.

7. FDA Approves Aficamten (Myqorzo) for Symptomatic Obstructive Hypertrophic Cardiomyopathy

On December 19, 2025, the FDA approved Cytokinetics’ aficamten (Myqorzo) for adults with symptomatic obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms. The decision was based on phase 3 SEQUOIA-HCM results showing clinically meaningful improvements across exercise capacity, symptoms, and cardiac hemodynamics. The approval includes a Boxed Warning for heart failure risk and requires use under a REMS program.

8. FDA Approves Semaglutide (Wegovy) Pill As First Oral GLP-1 for Weight Loss

On December 22, 2025, the FDA approved Novo Nordisk’s once-daily oral semaglutide (Wegovy), the first oral GLP-1 therapy for obesity in the US. The approval, based on the 64-week phase 3 OASIS 4 trial, showed adults taking semaglutide with diet and exercise lost an average of 17% of body weight versus 3% with placebo, with 76% achieving at least 5% weight loss. The approval adds to its existing indication of reducing major cardiovascular events in adults with overweight or obesity and established cardiovascular disease.

9. FDA Approves Narsoplimab (Yartemlea) As First TA-TMA Therapy

On December 24, 2025, the FDA approved Omeros Corporation’s narsoplimab-wuug (Yartemlea) for the treatment of hematopoietic stem cell transplant–associated thrombotic microangiopathy (TA-TMA) in adults and children ≥2 years, making it the first and only approved lectin pathway inhibitor. The approval was based on a single-arm study and expanded access program showing complete response rates of 61–68% and 100-day survival of 73–74% in high-risk patients, including those refractory to prior therapies.

10. FDA Approves Mitapivat (AQVESME) for Non-Transfusion-Dependent Alpha- and Beta-Thalassemia

On December X, 2025, the FDA approved Agios’ mitapivat (AQVESME) for the treatment of anemia in adults with alpha- or beta-thalassemia, covering both transfusion-dependent and non–transfusion-dependent patients. Approval was supported by the phase 3 ENERGIZE and ENERGIZE-T trials, which demonstrated significant improvements in hemoglobin response and reductions in transfusion burden, respectively, with a manageable safety profile. 

1. Brooks A. FDA Approves Omidubicel-onlv (Omisirge) As First Cellular Severe Aplastic Anemia Therapy. Article. HCPLive. December 8, 2025. https://www.hcplive.com/view/fda-approves-omidubicel-onlv-omisirge-first-cellular-severe-aplastic-anemia-therapy

2. Brooks A. FDA Approves Etuvetidigene Autotemcel (Waskyra) For Wiskott-Aldrich Syndrome. Article. HCPLive. December 9, 2025. https://www.hcplive.com/view/fda-approves-etuvetidigene-autotemcel-waskyra-wiskott-aldrich-syndrome

3. Derman C. FDA Approves Oral Berotralstat for Children Aged 2 – 11 Years with HAE. Article. HCPLive. December 12, 2025. https://www.hcplive.com/view/fda-approves-oral-berotralstat-children-aged-2-11-years-hae

4. Brooks A. FDA Approves Inebilizumab-cdon (Uplizna) for Generalized Myasthenia Gravis. Article. HCPLive. December 12, 2025. https://www.hcplive.com/view/fda-approves-inebilizumab-cdon-uplizna-generalized-myasthenia-gravis

5. Brooks A. FDA Approves Depemokimab-ulaa (Exdensur) for Severe Asthma. Article. HCPLive. December 17, 2025. https://www.hcplive.com/view/fda-approves-depemokimab-ulaa-exdensur-for-severe-asthma

6. FDA Approves Nerandomilast (Jascayd) Tablets for Progressive Pulmonary Fibrosis. Article. HCPLive. December 19, 2025. https://www.hcplive.com/view/fda-approves-nerandomilast-jascayd-tablets-for-progressive-pulmonary-fibrosis

7. Brooks A. FDA Approves Aficamten (Myqorzo) for Symptomatic Obstructive Hypertrophic Cardiomyopathy. Article. HCPLive. December 19, 2025. https://www.hcplive.com/view/fda-approves-aficamten-myqorzo-for-symptomatic-obstructive-hypertrophic-cardiomyopathy

8. Brooks A. FDA Approves Semaglutide (Wegovy) Pill As First Oral GLP-1 for Weight Loss. Article. HCPLive. December 23, 2025. https://www.hcplive.com/view/fda-approves-semaglutide-wegovy-pill-as-first-oral-glp-1-for-weight-loss

9. Brooks A. FDA Approves Narsoplimab (Yartemlea) As First TA-TMA Therapy. Article. HCPLive. December 24, 2025. https://www.hcplive.com/view/fda-approves-narsoplimab-yartemlea-as-first-ta-tma-therapy

10. Livingston R. FDA Approves Mitapivat (AQVESME) for Non-Transfusion-Dependent Alpha- and Beta-Thalassemia. Article. HCPLive. December 24, 2025. https://www.hcplive.com/view/fda-approves-mitapivat-aqvesme-for-non-transfusion-dependent-alpha--and-beta-thalassemia

Articles

December 2025 marked significant FDA approvals in various medical fields, including rare diseases, hematology, pulmonology, cardiology, and metabolic disorders. Notable approvals included omidubicel-onlv and etuvetidigene autotemcel for severe aplastic anemia and Wiskott-Aldrich syndrome, respectively, offering new transplant-based options. Pediatric care saw advancements with berotralstat and narsoplimab for hereditary angioedema and TA-TMA. Other approvals included therapies for generalized myasthenia gravis, severe asthma, progressive pulmonary fibrosis, and obesity, with semaglutide becoming the first oral GLP-1 therapy for weight loss.

This FDA News Month in Review provides a round-up of regulatory decisions from December 2025.

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10 FDA Headlines You Missed in December 2025

Rheumatoid arthritis (RA) care in 2025 reflected both accelerating innovation and a growing appreciation of the disease’s systemic complexity. Advances spanned regulatory milestones, late-phase clinical data, and population-level analyses, underscoring how RA management is evolving beyond joint inflammation alone to encompass neuroimmune pathways, cardiometabolic risk, mental health, and long-term comorbidity prevention.

At the regulatory and therapeutic level, the FDA approval of the first neuroimmune modulation device for RA marked a notable departure from traditional pharmacologic immunosuppression, while investigational agents such as rosnilimab continued to demonstrate durable, best-in-disease efficacy profiles in mid-stage trials. At the same time, emerging real-world and retrospective data highlighted unexpected therapeutic intersections, including the potential role of GLP-1 receptor agonists in improving RA disease activity alongside cardiovascular risk factors in patients with overweight or obesity.

Beyond treatment innovation, 2025 data reinforced the widening global burden of RA and the importance of early, holistic disease control. Large-scale epidemiologic analyses showed rising incidence and disability despite falling mortality, while cohort studies linked depression to reduced remission rates and demonstrated that prompt, effective therapy can improve prothrombotic abnormalities early in the disease course. Together, these developments illustrate a year in which RA research increasingly aligned innovation with outcomes that matter across the full spectrum of patient health.

FDA Approves Neuroimmune Modulation Therapy for Rheumatoid Arthritis

The FDA has approved SetPoint Medical’s SetPoint System, the first neuroimmune modulation device for rheumatoid arthritis, offering a novel implantable therapy that stimulates the vagus nerve to reduce inflammation without immune suppression. In the pivotal RESET-RA trial, the device significantly improved ACR20 response rates at 12 weeks, with benefits sustained through 12 months and a favorable safety profile.

Rosnilimab Continues Best-in-Disease Profile Responses for Rheumatoid Arthritis

Updated 6-month data from the phase 2b RENOIR trial showed rosnilimab sustained strong efficacy in moderate-to-severe rheumatoid arthritis, with durable responses and deepening disease activity improvements over time. The PD-1–targeting therapy demonstrated efficacy on par with JAK inhibitors but with a favorable safety profile and immune-restorative effects, supporting its potential as a long-term treatment option.

GLP-1 RA Use Improves Disease Activity, Cardiovascular Risk in Rheumatoid Arthritis

A retrospective study of patients with rheumatoid arthritis and overweight or obesity found that GLP-1 receptor agonists were associated with improvements in disease activity, pain, and cardiometabolic risk factors. Compared with controls, patients receiving semaglutide or tirzepatide had greater reductions in RA activity scores, weight, cholesterol, HbA1c, and inflammatory markers, though discontinuation rates were notable due to gastrointestinal side effects and insurance issues.

Rheumatoid Arthritis Burden Has Surged Over Last 30 Years

A large AI-driven analysis of rheumatoid arthritis (RA) trends across 953 global locations revealed a 13.2% rise in RA incidence since 1990, affecting 17.9 million people in 2021, with a shift toward younger populations. While age-standardized RA mortality dropped by 32.7% since 1980, global RA-related DALYs nearly doubled, highlighting an expanding burden despite medical advances. The study also pinpointed local hotspots—like West Berkshire, UK, with the highest incidence—and demonstrated that targeted interventions, such as smoking reduction, could substantially lower RA burden, emphasizing the importance of localized strategies beyond socioeconomic status alone.

Depression Reduces Remission Likelihood in Rheumatoid, Psoriatic Arthritis

New data from the tREACH and DEPAR cohorts suggest depressive symptoms within the first 2 years of diagnosis significantly reduce the likelihood of achieving remission in both rheumatoid arthritis and psoriatic arthritis, while anxiety was not independently associated after adjustment. The findings reinforce depression as a modifiable, clinically relevant factor in inflammatory arthritis outcomes and highlight the importance of early mental health recognition alongside disease-directed treatment.

Early Control of Rheumatoid Arthritis Improves Hemostatic Imbalance

Effective antirheumatic therapy significantly improved procoagulant and fibrinolytic abnormalities in patients with newly diagnosed RA over 24 weeks, with biologics—particularly the IL-6 receptor inhibitor tocilizumab—showing the greatest normalization of hemostatic markers. The findings suggest early, targeted RA treatment may help mitigate elevated thrombosis risk, reinforcing the importance of controlling inflammation while balancing cardiovascular safety considerations.

Johnson V. FDA Approves Neuroimmune Modulation Therapy for Rheumatoid Arthritis. Article. HCPLive. August 14, 2025. https://www.hcplive.com/view/fda-approves-neuroimmune-modulation-therapy-for-rheumatoid-arthritis

Johnson V. Rosnilimab Continues Best-in-Disease Profile Responses for Rheumatoid Arthritis. Article. HCPLive. August 20, 2025. https://www.hcplive.com/view/rosnilimab-continues-best-in-disease-profile-responses-rheumatoid-arthritis

Brooks A. GLP-1 RA Use Improves Disease Activity, Cardiovascular Risk in Rheumatoid Arthritis. Article. HCPLive. September 16, 2025. https://www.hcplive.com/view/glp-1-ra-use-improves-disease-activity-cardiovascular-risk-rheumatoid-arthritis

Johnson V. Rheumatoid Arthritis Burden Has Surged Over Last 30 Years. Article. HCPLive. https://www.hcplive.com/view/rheumatoid-arthritis-burden-has-surged-over-last-30-years

Brooks A. Depression Reduces Remission Likelihood in Rheumatoid, Psoriatic Arthritis. Article. HCPLive. June 17, 2025. https://www.hcplive.com/view/depression-reduces-remission-likelihood-rheumatoid-psoriatic-arthritis

Johnson V. Early Control of Rheumatoid Arthritis Improves Hemostatic Imbalance. January 10, 2025. https://www.hcplive.com/view/early-control-rheumatoid-arthritis-improves-hemostatic-imbalance


Rheumatoid arthritis management in 2025 has evolved significantly, focusing on systemic complexity beyond joint inflammation. Innovations include the FDA's approval of a neuroimmune modulation device and promising results from investigational agents like rosnilimab. Real-world data suggest GLP-1 receptor agonists may improve RA activity and cardiovascular risk. Despite medical advances, RA incidence and disability are rising, emphasizing the need for early, holistic disease control. Depression is identified as a modifiable factor affecting remission rates, and early RA treatment shows potential in addressing hemostatic imbalances.

The rheumatoid arthritis year in review highlights FDA approvals, data, and advances in 2025.

Rheumatoid Arthritis

The HCPLive rheumatoid arthritis page is a comprehensive resource for clinical news and insights on arthritis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for RA, and more.

Rheumatoid Arthritis in 2025: Year in Review

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.

Endocrinology experienced staggering growth across the board in 2025. Glucagon-like peptide-1 (GLP-1) receptor agonists have led the charge against 

, while also evolving into a key component in the management of 

 and cardiovascular complications associated with these conditions. Additionally, 

 approvals for the Biolinq Shine and Dexcom’s G7 15 Day continuous glucose monitoring system (CGM) are beginning to address the day-to-day challenges faced by many patients with both 

With so much movement in the sphere in the last 12 months, it was challenging to keep up with every bit of news coming out. The editorial team at 

 has put together a highlight reel of the 13 most impactful headlines in the endocrinology space from 2025 – catch up on some of the news you may have missed below.


FDA Approves Semaglutide (Ozempic) for Type 2 Diabetes, Chronic Kidney Disease


On January 28, 2025, the FDA approved semaglutide to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular disease death in patients with T2D and CKD. The decision was based on the phase 3b FLOW kidney outcomes trial, which highlighted semaglutide’s superior 24% relative risk reduction of all 3 endpoints compared to placebo when added to standard care.



On April 10, 2025, the FDA granted clearance to the Dexcom G7 15-day CGM system for patients with diabetes aged ≥18 years. With this approval, the G7 CGM is the longest-lasting CGM system, with 15.5 days of wear and best-in-class accuracy with a mean absolute relative difference of 8%. The device offers a waterproof sensor, direct connectivity to Apple watches, and automated activity logging, accompanied by a 12-hour grace period for transition for sensor replacement.


FDA Approves Label Expansion for Osilodrostat for Cushing's Syndrome


On April 16, 2025, parent company Recordati announced the FDA’s approval of a label extension for osilodrostat to treat endogenous hypercortisolemia in adults with Cushing’s syndrome who cannot undergo surgery or for whom it was not curative. The decision was based on the phase 3 LINC 3 study, which saw 137 patients with persistent or recurrent Cushing’s disease treated with twice-daily osilodrostat exhibit a rapid reduction in mean 24-hour urinary free cortisol concentration.


FDA Approves Lonapegsomatropin-tcgd (Skytrofa), Formerly TransCon hGH, for Adult Growth Hormone Deficiency


Lonapegsomatropin-tcgd received FDA approval on July 28, 2025, to replace endogenous growth hormone in adults with 

. This approval was based on data from foresiGHt, a phase 3 randomized clinical trial comparing weekly lonapegsomatropin-tcgd to weekly placebo and daily somatropin. After analysis, investigators saw lonapegsomatropin-tcgd showed superiority in reducing trunk fat and increasing total body lean mass at week 38 versus placebo. It was also safe and well-tolerated, with no discontinuations related to the study drug.


FDA Grants De Novo Classification to Needle-Free Glucose Monitor

On September 25, 2025, the FDA granted De Novo Classification to the Biolinq Shine, the first wearable glucose biosensor that does not require a needle for sensor placement. The device makes use of a microsensor array, which is up to 20 times more shallow than conventional glucose sensors, and aims to combine glucose, activity, and sleep information into a single device with autonomous operation. The Biolinq Shine takes the form of a patch placed on the forearm, displaying real-time glucose feedback via a primary color-coded LED display.


Oral GLP-1 Orforglipron Hits Target in Phase 3 Diabetes Trial


Results from the ACHIEVE-1 trial, published on April 17, 2025, displayed the efficacy and safety of oral orforglipron for adults with T2D inadequately controlled by diet and exercise. The once-daily GLP-1 receptor agonist lowered A1c by an average of 1.3-1.6% from a baseline of 8%, with >65% of individuals on the highest dose achieved A1c ≤6.5% - which is below the American Diabetes Association (ADA)’s threshold for diabetes. Patients also experienced an average weight loss of 16 lbs at the highest orforglipron dose, and parent company Eli Lilly noted no sign of a weight plateau by the end of the study.


CATALYST Trial: Mifepristone Improves Glycemic Control in Type 2 Diabetes with Hypercortisolism


Data from the phase 4 CATALYST trial showed the efficacy of mifepristone in improving glycemic control, reducing body weight, and decreasing waist circumference in patients with hypercortisolism and T2D. Mifepristone was associated with a least-squares mean difference in HbA1c of -1.3% compared to placebo, and secondary outcomes also suggested use was associated with weight loss and waist circumference reduction compared to placebo.


SURMOUNT-5: Tirzepatide (Zepbound) Proves Benefit over Semaglutide (Wegovy) for Obesity


Full data from the SURMOUNT-5 was released on May 11, 2025, highlighting tirzepatide’s more substantial weight reduction compared to semaglutide in patients with overweight and obesity. The trial enrolled 751 patients, who were randomly assigned in a 1:1 ratio to the maximum tolerated dose of either tirzepatide or semaglutide. Patients treated with tirzepatide exhibited a 20.2% reduction in body weight, compared to 13.7% with semaglutide. Similarly, absolute weight loss was greater with tirzepatide, at 22.8 kg versus 15 kg. Both medications also had consistent safety profiles.


SURPASS-PEDS: Tirzepatide Achieves Superiority to Placebo in Adolescent T2D


The phase 3 SURPASS-PEDS trial was presented at the European Association for the Study of Diabetes Annual Meeting 2025, highlighting tirzepatide’s efficacy compared to placebo in patients 10-18 years with T2D inadequately controlled with metformin, basal insulin, or both. Investigators found that pooled tirzepatide doses from the trial lowered A1c by an average of 2.2% from baseline, and 86.1% of patients assigned to tirzepatide 10 mg achieved a target A1c of ≤6.5%. Tirzepatide also led to meaningful improvements in BMI, with improvements continuing through a long-term extension of 52 weeks.


ACHIEVE-3: Orforglipron Superior to Semaglutide for Type 2 Diabetes in Phase 3 Trial


On September 18, 2025, Eli Lilly announced the results from their phase 3 ACHIEVE-3 trial, which proved orforglipron’s superiority to semaglutide in T2D inadequately controlled with metformin. The trial included 4 active treatment arms, aiming to assess glycemic control and weight loss; by 52 weeks, orforglipron met the primary and all key secondary endpoints across both treatment arms. Orforglipron 12 mg lowered A1c by an average of 1.9%, while the 36 mg dose lowered it by 2.2%, compared to 1.1% and 1.4% with oral semaglutide at 7 mg and 14 mg, respectively. Orforglipron was also superior to oral semaglutide for weight loss, with orforglipron recipients losing an average of 14.6 lbs (12 mg) and 19.7 lbs (36 mg) compared to 7.9 and 11 lbs with oral semaglutide at 7 and 14 mg, respectively.


Diabetes Dialogue: 2025 Guideline Updates for Diabetes & Pregnancy


In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discussed the July 2025 Preexisting Diabetes in Pregnancy guidelines. Comprised of 10 key recommendations aimed at improving outcomes in pregnant individuals with type 1 or 2 diabetes, these guidelines included discontinuing GLP-1 RAs prior to conception, avoidance of metformin during pregnancy due to concerns of fetal outcomes, and the use of a hybrid closed-loop insulin delivery system rather than standard pumps.


Diabetes Dialogue: Results of ATTAIN-1 and STEP UP Phase 3 Trials


In this episode of Diabetes Dialogue, Isaacs and Bellini covered the results of the ATTAIN-1 and STEP UP clinical trials, both of which had been presented at the European Association for the Study of Diabetes 2025 Conference. They discuss the success of orforglipron, a non-peptide GLP-1 receptor agonist, in patients with obesity or overweight and without diabetes – orforglipron’s status as an oral rather than injected GLP-1 was a key focus of the discussion. Additionally, the STEP UP trial investigating semaglutide 7.2 mg in adults with obesity marks a meaningful success for a substantially higher dose than what has been approved by the FDA.


Diabetes Dialogue: Therapeutic Updates from the ADA 2026 Standards of Care


In this episode of Diabetes Dialogue, Isaacs and Bellini cover the recently released 2026 ADA Standards of Care, emphasizing therapeutic changes that may be practice-changing. GLP-1 RAs are now recommended for both 

 and CKD, and the Standards have added time-in-range goals to glucose monitoring alongside A1c targets. Additionally, Isaacs and Bellini express their excitement over the first-ever recommendation for GLP-1 RAs in patients with T1D and obesity, describing it as a major step forward, albeit a first one.

Endocrinology saw significant advancements in 2025, with GLP-1 receptor agonists playing a pivotal role in managing type 2 diabetes, obesity, chronic kidney disease, and cardiovascular complications. The FDA approved several key treatments, including semaglutide for T2D and CKD, and the Dexcom G7 CGM system. Trials like ACHIEVE-1 and SURMOUNT-5 demonstrated the efficacy of new treatments such as orforglipron and tirzepatide. Updated guidelines and therapeutic recommendations were discussed in podcasts, highlighting the evolving landscape of diabetes management and treatment strategies.

Catch up on the most impactful headlines in dyslipidemia from all of 2025 with our Year in Review.

Endocrinology in 2025: Year in Review

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.

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

Diabetes Dialogue: Breaking New Ground With Oral GLP-1s in Cardiology and Weight Loss

In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, provide an in-depth discussion of the FDA approval of oral semaglutide (oral Wegovy) for chronic weight management, with market availability anticipated as early as January 2026. The conversation centers on the clinical, regulatory, and practical implications of introducing the first oral GLP-1 receptor agonist approved specifically for weight loss, long-term weight maintenance, and cardiovascular risk reduction.

00:00:01 Intro
00:00:12 Oral Wegovy is now FDA approved
00:02:16 Cardiovascular reduction from an oral GLP-1?
00:04:55 Oral versus injectable weight loss medications
00:05:21 Specific instructions for taking oral GLP-1s
00:10:10 Uptake of oral semaglutide
00:12:12 Orforglipron versus semaglutide
00:13:37 Outro

The hosts review the evidence underpinning approval, focusing on phase 3 data from the OASIS program, including OASIS 4, which enrolled more than 300 participants, and supporting trials encompassing over 17,000 patients. Oral semaglutide, titrated up to 25 mg once daily, produced up to 14% mean weight loss at 64 weeks compared with approximately 2% with placebo – this demonstrated durable, long-term efficacy rather than short-term weight reduction. Isaacs and Bellini highlight the importance of the extended follow-up period and the consistency of weight loss outcomes, particularly given longstanding concerns about sustainability with obesity pharmacotherapy.

The discussion then shifts to the cardiovascular indication recently granted to oral semaglutide. The hosts explain that cardiovascular outcomes were not directly studied at the 25-mg oral dose in a dedicated outcomes trial. Instead, the FDA accepted extrapolation from the SELECT trial, in which injectable semaglutide 2.4 mg weekly demonstrated a 20% reduction in major adverse cardiovascular events, along with prior cardiovascular outcomes data from oral semaglutide in type 2 diabetes. Isaacs underscores the significance of this regulatory decision, noting that it avoids redundant, costly trials and accelerates patient access to therapies with well-established class effects.

The episode also addresses real-world considerations that will influence uptake. The anticipated lower cash price – reported at approximately $149 – could substantially improve access, particularly compared with injectable GLP-1–based weight loss therapies. The hosts discuss patient preferences, noting that an oral option may appeal to individuals hesitant about injections and may offer a greater sense of control despite similar pharmacokinetics and side-effect profiles.

At the same time, Isaacs and Bellini stress the critical role of patient education. Oral semaglutide requires strict administration conditions, including ingestion with limited water and no food or beverages for at least 30 minutes, as well as careful dose titration. Pills cannot be split or doubled, and improper use may significantly reduce absorption and efficacy. The episode concludes with a forward-looking discussion of payer dynamics, step-therapy considerations, and emerging oral GLP-1 agents, positioning oral semaglutide as a potentially transformative addition to obesity and cardiovascular risk management in clinical practice.

Podcasts

Cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the groundbreaking news of oral semaglutide's approval and its cardioprotective benefits. 

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

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.

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.

Curcumin, vitamin D, and XP-828L appear to be the most promising dietary supplements for addressing 

 based on mechanistic plausibility, directional consistency, and favorable tolerability, new data suggest.

These results and others were drawn from a network meta-analysis (NMA) written to assess and rank the effectiveness and safety of various dietary supplements in patients with psoriasis. The data, authored by such investigators as Danping Chen, MD, of Heilongjiang University of Chinese Medicine, highlighted several potential adjunctive options for patients prior to evaluation.

These supplements included vitamin D, omega-3 fatty acids, probiotics, selenium, curcumin, micronutrients, and XP-828L. Typical psoriasis 

, Chen et al noted, carry adverse effects, as well as adherence considerations and limited drug survival in routine practice.

“Unlike earlier reviews limited to single supplements or pairwise comparisons, this study jointly evaluates multiple supplements and outcomes in a coherent framework,” Chen and colleagues said.

 “The objective is to conduct an NMA comparing and ranking the effectiveness and safety of dietary supplements as adjunctive therapy for plaque psoriasis.”

The investigative team set out to conduct an NMA that would compare and rank adjunctive dietary supplements for plaque psoriasis by safety and efficacy, with the team integrating both direct and indirect evidence from Chinese- and English-language sources. Chen and colleagues' aim was to generate clinically meaningful effect estimates with quantified uncertainty that could support individualized treatment decisions on supplement use.

A set of 8 databases, including China National Knowledge Infrastructure (CNKI), WanFang, VIP Chinese Science and Technology Journal Database, Cochrane Library, PubMed, SinoMed, Embase, and Web of Science, were searched by 2 investigators from the time of database inception through March 2025. The investigators' strategy involved the use of the term “psoriasis” alongside an extensive array of keywords which were supplement-related. Such keywords included minerals, nutritional, food, herbal supplements, vitamins, folic acid, probiotics, coenzyme Q10, fish oil, amino acids, cherry extract, turmeric, and celery seed extract.

Assessment of risk of bias for included research was done via the Cochrane Risk of Bias 2 (RoB 2) tool, which examines 5 methodological domains: the randomization process, completeness of outcome data, deviations from intended interventions, outcome measurement, and selective reporting. Each domain was classified by Chen and coauthors as lower risk, some concerns, or high risk. 21 randomized controlled trials (RCTs), encompassing a total of 1463 patients with psoriasis, were shown by the investigators to have met the necessary criteria to be included in the NMA. The interventions evaluated across these RCTs included XP-828L, vitamin D, fish oil, probiotics, selenium, curcumin, and diifferent micronutrient formulations.

In their evaluation of primary outcomes, Chen et al looked into any shifts in Dermatology Life Quality Index (DLQI), Psoriasis Area and Severity Index (PASI), physician global assessment (PGA), the incidence of adverse events (AEs), and inflammatory biomarkers [interleukin (IL)-6, IL-17, IL-23, and IL-22]. A frequentist NMA was conducted by the investigators using Stata version 17.0. They generated supplement rankings via the surface under the cumulative ranking curve (SUCRA).

Findings on Dietary Supplements for Psoriasis

Across these 21 RCTs, supplementation with vitamin D was linked with a statistically significant PASI score reduction, with a mean difference of −3.29 (95% CI, −6.38 to −0.20). Additionally, the investigative team found XP-828L showed the highest probability of DLQI and PGA score outcome improvements. The use of vitamin D alongside narrowband ultraviolet B (NB-UVB) therapy was shown to have the most consistent IL-6, IL-17, and IL-23 level reductions among patients. The team also pointed to a link between curcumin and decreases in levels of IL-22.

There was not a meaningful distinction between AE rates in the different interventions, with a pooled risk ratio of 1.02 (95% CI, 0.94–1.10). There was no single supplement shown by Chen and coauthors to have emerged as superior across all measured outcomes. The overall certainty of evidence was determined to be low to moderate, and this was largely due to heterogeneity and imprecision.

These data support a personalized approach to psoriasis treatment supplementation. The findings underscore the importance of additional, larger, and well-designed RCTs with standardized dosing regimens as well as longer follow-up periods.

“No single dietary supplement optimally addresses all indicators in plaque psoriasis,” Chen et al concluded.

 “This NMA (21 RCTs) highlights the differential roles of key supplements: Patterns observed across supplements suggest complementary roles: vitamin D appears more relevant to systemic inflammation, XP-828L to quality-of-life domains, and curcumin to IL-22-linked inflammatory pathways.”

Chen D, Yang J, Li Z, et al. Effectiveness and safety of dietary supplements in the adjunctive treatment of psoriasis: a systematic review and network meta-analysis. Front Nutr. 2025 Dec 11;12:1718828. 

Shi YL. Interpretation of the Chinese psoriasis guidelines (2023 edition). J Tongji Univ (Med Sci). (2023) 44:631–3.

Curcumin, vitamin D, and XP-828L are promising dietary supplements for psoriasis, offering mechanistic plausibility, consistency, and tolerability. A network meta-analysis evaluated these supplements' effectiveness and safety, highlighting their potential as adjunctive treatments. The study involved 21 randomized controlled trials with 1463 psoriasis patients, assessing outcomes like PASI, DLQI, PGA, and inflammatory biomarkers. Vitamin D showed significant PASI reduction, XP-828L improved quality-of-life scores, and curcumin reduced IL-22 levels. No single supplement was superior across all outcomes, emphasizing the need for personalized treatment approaches.

Investigators conducted a network meta-analysis comparing and ranking the safety and efficacy of dietary supplements as adjunctive therapy for patients with psoriasis.

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Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

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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.

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