Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. 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.

December 2025 capped a transformative year in 

 and immunology, with late-breaking regulatory decisions, pivotal trial results, and emerging clinical insights reinforcing the rapid pace of change across the field. This month in review highlights key developments shaping day-to-day practice, including new and forthcoming therapies for hereditary angioedema (HAE), advances in food allergy management, and data that further refine treatment selection and patient counseling.

For clinicians, December’s updates underscore a broader shift toward more personalized, less burdensome care, particularly for pediatric and multi-allergic populations, while setting the stage for continued innovation heading into 2026.

FDA Approved Another HAE Treatment on December 12th

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

The US Food and Drug Administration (FDA) has approved berotralstat (ORLADEYO) oral granules for children aged 2 to 11 years with HAE, marking the first FDA-approved oral prophylactic therapy designed for this pediatric population. Announced by BioCryst Pharmaceuticals, the approval addresses a longstanding treatment gap for children under 12. The decision was supported by positive interim data from the APeX-P trial, demonstrating sustained reductions in HAE attack rates and a safety profile consistent with adults. Experts from institutions, including UCLA, highlighted the reduced treatment burden compared with injectable therapies, expanding long-term management options for pediatric HAE.

Pharvaris’ Deucrictibant Provides Rapid Relief for HAE in Phase 3 RAPIDe-3 Trial

Pharvaris’ oral bradykinin B2 receptor antagonist deucrictibant met its primary endpoint in the phase 3 RAPIDe-3 trial, providing rapid relief of HAE attacks in under 90 minutes. In the global, placebo-controlled study of 134 patients aged ≥ 12 years, deucrictibant significantly shortened time to symptom onset, substantial relief, and complete resolution versus placebo. Most attacks were controlled with a single 20-mg dose, and > 93% required no rescue medication. The therapy was well tolerated, with no treatment-related serious adverse events. Pharvaris plans to submit a New Drug Application (NDA) to the FDA in 2026.

Allergy Field Spotlights from Our This Year in Medicine Series

A New Era in Food Allergy Treatment: The Push Toward Multi-Allergen Immunotherapy

Food allergy care is entering a new phase as clinicians push toward therapies that address multiple allergens simultaneously. Following the FDA approval of omalizumab (Xolair) in 2024, experts report meaningful quality-of-life improvements for patients with multiple food allergies by increasing reaction thresholds, though it is not curative.

With food allergy prevalence up 50% since the 1990s, 2025 research highlighted renewed interest in multi-allergen oral immunotherapy (OIT), including investigational ADP101, and growing momentum for sublingual immunotherapy. Despite mixed trial results, clinicians see promise in raising thresholds across several foods. With evolving prevention strategies and new devices, these advances signal a shifting landscape in food allergy management.

Rare Disease, Rapid Progress: FDA's HAE Approvals in 2025 Signal Changing Course

Before berotralstat, the FDA approved 3 other new HAE therapies—garadacimab-gxii (Andembry), sebetralstat (Ekterly), and donidalorsen (Dawnzera)—marking a major expansion in treatment options for this rare genetic disease. Experts from UCLA Health and the University of Colorado highlighted how these approvals enable more personalized care through novel mechanisms, oral and injectable options, and less frequent dosing.

Despite this rapid progress, clinicians emphasized persistent unmet needs, particularly for pediatric patients under 12 years and for therapies that improve portability and access. Overall, the 2025 approvals signal a turning point in HAE management and research momentum.

As 2025 came to an end, we put together a year-in-review that reflects the most impactful developments that shaped allergy and immunology over the past 12 months. From landmark FDA approvals to pivotal trial readouts and evolving clinical guidance, 2025 marked a period of accelerated progress across both rare and common allergic diseases.

Breakthroughs in HAE expanded preventive and on-demand options, while advances in food allergy prevention, immunotherapy, and anaphylaxis management influenced everyday clinical practice. These highlights capture a year defined by therapeutic innovation, growing personalization of care, and meaningful shifts in how clinicians approach allergy management across the lifespan.

Articles

December 2025 marked significant advancements in allergy and immunology, with pivotal regulatory decisions and trial results shaping clinical practice. Key developments included FDA approval of berotralstat for pediatric hereditary angioedema (HAE), promising phase 3 results for deucrictibant, and progress in multi-allergen immunotherapy for food allergies. These updates highlight a shift towards personalized, less burdensome care, especially for pediatric and multi-allergic populations. The year concluded with a focus on therapeutic innovation and evolving strategies in allergy management, setting the stage for continued progress in 2026.

December highlights: FDA approval of berotralstat for pediatric HAE, phase 3 RAPIDe-3 results, and allergy field spotlights in our This Year in Medicine series.

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5 Allergy Headlines You Missed in December 2025

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration (FDA) 510(k) clearance of StimLabs’ Theracor for wound care, the approval of tradipitant (Nereus) for motion sickness, Complete Response Letters (CRL) for Corcept Therapeutics’ New Drug Application for relacorilant for hypercortisolism and Outlook Therapeutics’ ONS-5010 for the treatment of wet age-related macular degeneration, and the acceptance and Priority Review of Axsome Therapeutics’ supplemental New Drug Application for AXS-05 for the treatment of agitation in Alzheimer’s disease.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of December 28, 2025—let’s jump in!

FDA Grants 510(k) Clearance to First Umbilical Cord–Derived Sheet Formulation for Wound Care

On December 29, 2025, the FDA granted 510(k) clearance to StimLabs’ Theracor, the first human umbilical cord–derived medical device offered in a sheet formulation. The clearance builds upon the Agency’s prior authorization of Corplex P, the first FDA 510(k) cleared human umbilical cord-derived medical device for wound management provided in a particulate format.

FDA Approves Tradipitant (NEREUS) for the Prevention of Vomiting Induced by Motion

On December 30, 2025, the FDA approved Vanda Pharmaceuticals’ tradipitant under the brand name Nereus for the prevention of vomiting induced through motion sickness. The decision marked the first new pharmacologic treatment in motion sickness in more than 4 decades and was based on data from a pair of phase 3 trials, Motion Syros and Motion Serifos, showing lower vomiting and severe nausea with tradipitant versus placebo.

FDA Issues Complete Response Letter for Relacorilant for Hypercortisolism

On December 31, 2025, the FDA issued a CRL to Corcept Therapeutics’ New Drug Application for relacorilant for hypercortisolism. While the Agency acknowledged the GRACE trial met its primary endpoint and that data from the GRADIENT trial provided confirmatory evidence, the FDA concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness.

FDA Issues Complete Response Letter for ONS-5010 for Wet AMD

On December 31, 2025, the FDA issued a CRL to Outlook Therapeutics’ ONS-5010 for the treatment of wet age-related macular degeneration. The latest CRL adds to 2 previous CRLs in ONS-5010’s lengthy regulatory road, with the FDA determining that the additional mechanistic and natural history data provided in the newest resubmission failed to alter the previous review conclusion, which stated that confirmatory evidence of efficacy must be submitted to support the application. At the time of the CRL, the FDA had not yet indicated what type of confirmatory evidence would be acceptable.

FDA Accepts, Grants Priority Review to AXS-05 sNDA for Alzheimer’s Disease Agitation

On December 31, 2025, the FDA accepted and granted Priority Review to Axsome Therapeutics’ supplemental New Drug Application (sNDA) for AXS-05 for the treatment of agitation in Alzheimer’s disease, setting a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026. The sNDA was supported by data from the comprehensive clinical development program of AXS-05 in Alzheimer’s disease agitation, including 4 randomized, double-blind, controlled phase 3 clinical trials and a long-term safety trial.

Hillenbrand A. FDA Grants 510(k) Clearance to First Umbilical Cord–Derived Sheet Formulation for Wound Care. HCPLive. December 29, 2025. Accessed January 2, 2025. 

https://www.hcplive.com/view/fda-grants-510-k-clearance-first-umbilical-cord-derived-sheet-formulation-wound-care

Livingston R. FDA Approves Tradipitant (NEREUS) for the Prevention of Vomiting Induced by Motion. HCPLive. December 31, 2025. Accessed January 2, 2025. 

https://www.hcplive.com/view/fda-approves-tradipitant-nereus-for-the-prevention-of-vomiting-induced-by-motion

Livingston R. FDA Issues Complete Response Letter for Relacorilant for Hypercortisolism. HCPLive. December 31, 2025. Accessed January 2, 2025. 

https://www.hcplive.com/view/fda-issues-complete-response-letter-for-relacorilant-for-hypercortisolism

Livingston R. FDA Issues Complete Response Letter for ONS-5010 for Wet AMD. HCPLive. December 31, 2025. Accessed January 2, 2025. 

https://www.hcplive.com/view/fda-issues-complete-response-letter-for-ons-5010-for-wet-amd

Livingston R. FDA Accepts, Grants Priority Review to AXS-05 sNDA for Alzheimer’s Disease Agitation. HCPLive. December 31, 2025. Accessed January 2, 2025. 

https://www.hcplive.com/view/fda-accepts-grants-priority-review-to-axs-05-snda-for-alzheimer-s-disease-agitation

The FDA has granted 510(k) clearance to StimLabs’ Theracor, a novel umbilical cord-derived sheet for wound care. Tradipitant, branded as Nereus, received FDA approval for motion sickness, marking the first new treatment in over 40 years. Corcept Therapeutics’ relacorilant for hypercortisolism and Outlook Therapeutics’ ONS-5010 for wet AMD both received Complete Response Letters, requiring additional evidence. Axsome Therapeutics’ AXS-05 for Alzheimer’s agitation was accepted for Priority Review, with a target action date set for April 30, 2026.

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

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The HCPFive: Top News for Healthcare Providers from the Week of 12/28

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.

Weight-Adjusted Waist Index Predicts Cardiovascular Risk in Patients with T2D | Image Credit: Pexels

The weight-adjusted waist circumference index is closely associated with future cardiovascular outcomes and total mortality in patients with 

, according to a recent retrospective cohort analysis of data from the ACCORD trial.

“This retrospective cohort study is designed to investigate the correlation between [the weight-adjusted waist index] and cardiovascular outcomes within the participants of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) cohort, aiming to generate new insights that may support clinical practices and provide valuable references for risk assessment and tailored management strategies for adverse cardiovascular outcomes in T2DM patients,” Maojun Liu, MD, department of cardiovascular medicine, the Second Xiangya Hospital, Central South University, Hunan, China, and colleagues wrote.

ACCORD was a randomized, multicenter phase 3 trial conducted across 77 locations. The trial consisted of 3 arms, investigating whether lowering blood glucose, blood pressure, or LDL cholesterol levels past current guideline-recommended levels reduced cardiovascular disease risk. All 3 arms received intensive control, and each arm was accompanied by an active comparator cohort receiving standard control.

Investigators included patients with T2DM, determined by a fasting plasma glucose level >126 mg/dl or a 2-hour postload value in the oral glucose tolerance test of >200 mg/dl, as well as a history of cardiovascular disease in patients aged ≥40 years. To be included, patients ≥55 years were required to be at high risk for experiencing a cardiovascular event due to existing cardiovascular disease, subclinical disease, or ≥2 risk factors. Primary outcome measures for ACCORD included first occurrence of major cardiovascular events, including nonfatal heart attack, nonfatal 

Ultimately, 10,251 patients were enrolled in ACCORD, with a mean age of 62.2 years and a median HbA1c of 8.1%. The trial ultimately indicated no correlation between any of the 3 arms and reduced mortality due to cardiovascular disease events.

In this retrospective cohort analysis, Liu and colleagues collected baseline weight-adjusted waist index data from 10,148 patients from ACCORD, omitting 103 due to missing data. The primary endpoint for the study was the occurrences of major adverse cardiovascular events (MACEs) – specifically nonfatal myocardial infarctions, nonfatal strokes, and death from cardiovascular causes. The secondary endpoint examined composites of the above outcomes.

Using a Cox proportional hazards regression model, investigators found a correlation between higher weight-adjusted waist index quartiles and increased risk of MACEs, congestive heart failure, and total mortality. A median follow-up of 8.82 years revealed that 1803 patients (17.77%) suffered MACE events. Additionally, 1927 total deaths and 690 congestive heart failure cases occurred during this follow-up period. These incidence rates were substantially increased in the higher quartiles.

Ultimately, investigators established that an increase of per 1 standard deviations (SD) in weight-adjusted waist index corresponded with a 7% increased risk of MACEs (HR, 1.07; 95% CI, 1.02-1.13), a 20% greater risk of congestive heart failure (HR, 1.2; 95% CI, 1.1-1.3), and an 11% increase in total mortality (HR, 1.11; 95% CI, 1.06-1.17). Subgroup analyses also demonstrated that the weight-adjusted waist index more accurately predicted congestive heart failure risk in patients whose diabetes duration was <10 years.

“Our research underscores the utility of the novel obesity metric, [the weight-adjusted waist index], as an effective predictor of adverse cardiovascular outcomes and overall mortality in T2DM patients,” Liu and colleagues wrote. “Maintaining [the weight-adjusted waist index] within a defined healthy range is associated with significant improvements in cardiovascular health and reductions in mortality. These observations highlight the importance of diligent monitoring of [weight-adjusted waist index] for clinical management and prevention, particularly in diabetic patients.”

Liu M, Pei J, Zeng C, Xin Y, Tang P, Hu X. Associations and predictive value of weight-adjusted waist index for cardiovascular outcomes in type 2 diabetes: evidence from the ACCORD study. Nutr J. 2025;24(1):184. Published 2025 Dec 17. 

National Heart, Lung, and Blood Institute (NHLBI). Action to Control Cardiovascular Risk in Diabetes (ACCORD) (ACCORD). ClinicalTrials.gov Identifier: NCT00000620. Updated November 22, 2016. Accessed January 2, 2026. 

https://clinicaltrials.gov/study/NCT00000620

The Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. New England Journal of Medicine. 2008;358(24):2545-2559. 

A retrospective cohort analysis of the ACCORD trial data reveals that the weight-adjusted waist circumference index is significantly associated with future cardiovascular outcomes and total mortality in patients with type 2 diabetes mellitus (T2DM). The study found that higher quartiles of this index correlate with increased risks of major adverse cardiovascular events (MACEs), congestive heart failure, and total mortality. The weight-adjusted waist index serves as a valuable predictor for adverse cardiovascular outcomes, emphasizing the importance of maintaining it within a healthy range for improved cardiovascular health and reduced mortality in T2DM patients.

A recent retrospective cohort analysis of the ACCORD phase 3 study has revealed a correlation between higher index values and increased mortality risk.

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Weight-Adjusted Waist Index Predicts Cardiovascular Risk in Patients with T2D

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

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

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.

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.

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

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.

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

Plaque Psoriasis

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

Dietary Supplements Aid in Psoriasis Treatment, Though Effect Estimates Vary

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.

In December 2025, intervention strategies, dialysis modalities, and kidney transplantation data provided insight to improve renal care for clinicians. 


Nephrology

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

6 Nephrology Headlines You Missed in December 2025

Sophia Thomas, DNP, APRN, FNP-BC, PPCNP-BC, FAANP, FNAP, FAAN, former president of the American Association of Nurse Practitioners and nurse practitioner at DePaul Community Health Centers

Nurse practitioners play a key role in allergy and asthma care using specific IgE blood testing to identify triggers, improve outcomes, and ease shortages.

Seasonal Allergy

Understanding Allergies from Bedside to Blood Test

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

Videos

Summary of the phase 3b APEX study showing guselkumab’s efficacy and inhibition of structural joint damage.

Video Series

Expert Perspectives on Rheumatologic Referral for Psoriatic Arthritis

The panel discusses the prevalence and risk factors for psoriasis progression to psoriatic arthritis.

Screening for Psoriatic Arthritis in Patients With Psoriasis 

Shyam Joshi explores the expected incorporation of new therapies within updated CSU guidelines and their anticipated impact on clinical management strategies.


Anticipated Role of New Therapies in CSU Guidelines, Management

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.

The 2025 cholangitis year in review covers PBC and PSC advances, FDA designations, trial data, and evolving treatment pathways.

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