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

 and chronic obstructive pulmonary disease (COPD) has been transformed over the past several years by the recognition that type 2 (T2) inflammation — characterized by eosinophilic infiltration, elevated fractional exhaled nitric oxide (FeNO), and IgE-mediated signaling — represents a distinct, therapeutically targetable biological axis across both conditions. In severe asthma, biologics targeting the interleukin (IL)-4/13, IL-5, IL-5 receptor alpha (IL-5Rα), and thymic stromal lymphopoietin (TSLP) pathways have accumulated robust, long-term efficacy and safety data. Dupilumab demonstrated sustained reductions in exacerbation rates and FEV1 improvements through 148 weeks in the TRAVERSE open-label extension,¹ while benralizumab showed a stable safety profile with no new signals over 5 years in the MELTEMI extension.² The most recent addition to the asthma biologic armamentarium, depemokimab — an ultra–long-acting anti-IL-5 monoclonal antibody — received FDA approval in December 2025 under the brand name Exdensur, supported by data from the phase 3 SWIFT-1 and SWIFT-2 trials demonstrating 58% and 48% reductions in annualized exacerbation rates vs placebo, respectively.³ In COPD, where the prevailing inflammatory paradigm historically centered on neutrophilic pathways, the landscape has shifted considerably: an estimated 20%–40% of patients with COPD harbor an eosinophilic phenotype associated with increased exacerbation risk,⁴ and both dupilumab and mepolizumab now carry regulatory approval as add-on therapies for this subset, based on the BOREAS/NOTUS and MATINEE trial programs, respectively.⁵˒⁶˒⁷

 convened a virtual clinical forum in March 2026 moderated by Joe Khabbaza, MD, a pulmonary and critical care physician at Cleveland Clinic, that featured 12 additional panelists — including pulmonologists, a critical care specialist, and a physician assistant — drawn from academic medical centers and community practices across the Midwest and Southeast United States. Participants included clinicians from Cleveland Clinic, practices in Altoona, Pennsylvania, Mishawaka, Indiana, Morehead, Kentucky, and Oakland, Illinois, and a pulmonologist practicing in Atlanta, Georgia — representing a range of clinical contexts from large academic systems to independent community practice.

The forum convened at a moment of particular relevance to the pulmonology community: clinicians now face a biologic landscape encompassing more approved agents than can be navigated by phenotype alone, alongside mounting pressure from payers, evolving questions about optimal sequencing, and an urgent need to define where emerging agents fit in day-to-day practice. The group's stated objectives — to examine biomarker-driven escalation criteria, identify real-world barriers to biologic initiation, and apply emerging trial data to patient selection in both asthma and COPD — addressed precisely the decision points that practitioners encounter across care settings. The GOLD 2026 report, which now formally includes dupilumab and mepolizumab as escalation options for patients with ongoing exacerbations, provided additional urgency to the COPD portion of the discussion.⁸

The most clinically substantive discussion in the asthma segment centered on biologic selection and the field's shift from a treatment goal of symptom control toward clinical remission. Panelists broadly agreed that phenotyping — primarily via blood eosinophil count, with FeNO as a secondary tool — underpins escalation decisions, with thresholds of 150 and 300 cells/µL anchoring most clinical reasoning. Dupilumab emerged as a common first-line choice for patients with elevated eosinophils and FeNO or allergic features, while tezepelumab was preferred for T2-low patients and those lacking clear phenotypic markers. Benralizumab showed a slight practical advantage over mepolizumab in at least 1 panelist's experience based on patient-perceived benefit. 

“Even if they are controlled, I think having an obsession of always knowing what somebody's EOS are, that's kind of been my biggest thing. And when I trained… I never thought about this stuff… Now it's just always what are their EOS and FeNO, most people have that biomarker already, which is kind of unique for a biomarker as well,” Khabbaza said.

Regarding depemokimab, the group identified the twice-yearly dosing schedule as most relevant for patients who require in-office biologic administration or who struggle with treatment adherence, while acknowledging that clinical experience is limited given the agent's recent approval. Mucus plugging data from VESTIGE⁹ and CASCADE¹⁰ were acknowledged as scientifically interesting — both trials demonstrated CT-assessed reductions in mucus plug scores with dupilumab and tezepelumab, respectively — but multiple panelists stated these findings have not changed their prescribing approach, as clinicians are not routinely obtaining CT scans to identify mucus plugging in the absence of other indications. A recurring theme across the asthma discussion was frustration with payer restrictions: prior authorization requirements, insurer unfamiliarity with T2 inflammation as a treatment rationale, and mandates to maintain inhaled corticosteroid therapy even when patients have achieved durable biologic-mediated control.

Turning to COPD, panelists reflected a field gaining practical confidence in biologic use but still working through significant uncertainties in patient selection and agent positioning. The eosinophilic COPD phenotype — driven by T2 inflammation independent of or concurrent with asthma overlap — was recognized as clinically meaningful, with panelists noting they now routinely check eosinophil counts in COPD patients and use them to guide both ICS use and biologic eligibility. When choosing between dupilumab and mepolizumab in COPD, the group relied heavily on study inclusion criteria: dupilumab was preferred for patients with eosinophils ≥300 cells/µL and chronic bronchitis predominance, while mepolizumab was favored for eosinophils in the 150–300 cells/µL range, severe airflow limitation (FEV1 <30%), and pure emphysema phenotypes. Clinical responses in COPD were described as slower to manifest and less dramatic than in asthma, reflecting the coexistence of irreversible obstruction and parenchymal disease alongside the treatable T2 component. 

“I think generally going to the biologics earlier in these patients just to avoid any amount of steroid if you can is a valuable goal. I was also going to mention the problem that I think probably many of us have had. The patients feel so well that they don't take their maintenance medications like they're supposed to. Then they get a ding from the insurance company, we're going to stop this stuff because you're not filling your maintenance. So just that subtle reminder that you feel so well, you don't need these other medications, you have to take them because otherwise we're going to get behind the evolved insurance people,” one panelist said.

Polling conducted during the forum revealed that approximately half of panelists identified payer support and reimbursement guidance as the factor that would most improve their ability to integrate biologics into COPD care — a finding that distilled much of the session's underlying tension. Unmet needs flagged by the group included an absence of approved targeted therapies for T2-low, neutrophilic-predominant COPD, with tezepelumab and anti-IL-33 agents under investigation; brensocatib was noted as an agent being explored off-label in patients with overlapping bronchiectasis.

Wechsler ME, Ford LB, Maspero JF, et al. Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study. 

 2022;10(1):11-25. doi:10.1016/S2213-2600(21)00322-2

Korn S, Bourdin A, Chupp G, et al. Integrated safety and efficacy among patients receiving benralizumab for up to 5 years. 

 2021;9(12):4381-4392.e4. doi:10.1016/j.jaip.2021.08.016

Jackson DJ, Wechsler ME, Menzies-Gow A, et al; SWIFT-1 and SWIFT-2 Investigators. Twice-yearly depemokimab in severe asthma with an eosinophilic phenotype. 

 2024;391(24):2337-2349. doi:10.1056/NEJMoa2406673

Vanetti M, Visca D, Ardesi F, et al. Eosinophils in chronic obstructive pulmonary disease. 

 2025;19:17534666251335800. doi:10.1177/17534666251335800

Bhatt SP, Rabe KF, Hanania NA, et al; BOREAS Investigators. Dupilumab for COPD with type 2 inflammation indicated by eosinophil counts. 

 2023;389(3):205-214. doi:10.1056/NEJMoa2303951

Bhatt SP, Rabe KF, Hanania NA, et al; NOTUS Investigators. Dupilumab for COPD with blood eosinophil evidence of type 2 inflammation. 

 2024;390(24):2274-2283. doi:10.1056/NEJMoa2401304

Criner GJ, Celli BR, Bhatt SP, et al. Mepolizumab for COPD with exacerbations and eosinophilia. 

 2023;389(23):2127-2138. doi:10.1056/NEJMoa2303120

Global Initiative for Chronic Obstructive Lung Disease. 

Global Strategy for Prevention, Diagnosis and Management of COPD: 2026 Report.

Porsbjerg CM, Dunican EM, Lugogo NL, et al. Effect of dupilumab on mucus burden in patients with moderate-to-severe asthma: the VESTIGE trial. 

 Published online October 27, 2025. doi:10.1164/rccm.202410-1894OC

Diver S, Khalfaoui L, Emson C, et al. Effect of tezepelumab on airway inflammatory cells, remodelling, and hyperresponsiveness in patients with moderate-to-severe uncontrolled asthma (CASCADE): a double-blind, randomised, placebo-controlled, phase 2 trial. 

 2021;9(11):1299-1312. doi:10.1016/S2213-2600(21)00226-5

Articles

Type 2 inflammation has become a unifying, actionable axis across severe asthma and an eosinophilic subset of COPD, expanding biologic options and complicating real-world sequencing. Biomarker-led escalation relies chiefly on blood eosinophils (150/300 cells/µL) with FeNO as support, alongside increasing emphasis on remission rather than symptom control. Twice-yearly depemokimab is viewed as adherence- and office-administration–friendly but remains early in adoption. In COPD, GOLD 2026 incorporation of dupilumab and mepolizumab accelerates uptake amid payer friction and residual gaps for T2-low disease.

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COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

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Biologics Across the Airway: Selection, Remission Goals, and Real-World Barriers

Nicole Chase, MD, is a board-certified allergist/immunologist at St. Paul Allergy Asthma, Minneapolis VA Health Care System (part-time), and an associate professor of medicine at the University of Minnesota Medical School.

 FDA Removes Age Restriction for Epinephrine Nasal Spray, With Nicole Chase, MD

The US Food and Drug Administration (FDA) recently eliminated the minimum age requirement for the 1 mg 

, allowing prescribing decisions to be guided by patient weight rather than age. The updated labeling now permits use in any patient weighing ≥ 33 pounds.

“We’ve been giving epinephrine safely to younger…and really lower-weight children for a long time,” said Nicole Chase, MD, an allergist/immunologist at St. Paul Allergy & Asthma and associate professor of medicine at the University of Minnesota Medical School. “Now [that] neffy can be prescribed for children that are 33 to 66 pounds in the 1 mg strength, it just mirrors what we've been used to doing for epinephrine auto injectors for the 0.15 mg strength.”

ARS Pharmaceuticals announced the FDA’s approval of the labeling update on March 27, 2026. Before the change, epinephrine nasal spray was indicated for pediatric patients aged ≥ 4 years who met weight-based criteria (1 mg for ≥33 lbs to <66 lbs; 2 mg for ≥66 lbs).

The updated label now guides use, temperature, and storage. A patient should avoid sniffing during dosing. Chase explained that inhaling deeply during delivery has been associated with most reported adverse effects.

“I encourage people to just breathe in through their nose, hold the device so that their fingers actually touch the outside nostrils, and then just depress the plunger so that they don't accidentally sniff when they administer it,” she said.

If a patient inadvertently sniffs after nasal administration, the label states to continue the care as normal. A patient does not need a second dose if symptoms improve within 5 minutes.

The updated label provides reassurance for families worried about environmental exposure. The nasal spray can tolerate brief temperature changes, including freezing followed by thawing, and short periods of heat exposure up to 122°F.

“I like to say, if you're comfortable, it's comfortable,” Chase said.

Counseling families on storage remains essential, she added. The label states that the device should be kept in its blister packaging or carrying case and stored at room temperature whenever possible. ARS Pharmaceuticals announced it plans to provide a carrying case with each prescription at no cost beginning this summer; the case is designed to hold 2 devices.

Chase also highlighted the longer shelf life of the nasal spray compared with many injectable epinephrine products, which may reduce the burden of frequent replacement. Intranasal epinephrine can also reduce needle anxiety.

She added that the availability of multiple delivery options allows clinicians to tailor recommendations to individual circumstances. For example, intranasal epinephrine may be particularly helpful for children attending camps, spending time outdoors, or in school settings where storage and usability are concerns.

In clinical practice, Chase has administered intranasal epinephrine during supervised food challenges and observed favorable tolerability among pediatric patients.

The removal of the age restriction may ultimately improve treatment adherence, which remains a significant challenge in anaphylaxis management. Chase emphasized that increasing comfort and accessibility could encourage earlier use of epinephrine during allergic reactions. She stressed that epinephrine remains safe and effective, and delays in administration pose greater risks than unnecessary use.

“If a [child] even think[s] they're having a reaction, I really want them to go ahead and take epinephrine,” Chase said. “I like to say that they can just ask for forgiveness instead of asking for permission. Epi is safe and effective, and it really prevents the bad [food allergy] outcomes.”

Relevant disclosures for Chase include GENZYME CORPORATION, Regeneron Healthcare Solutions, Incyte Corporation, Novartis Pharmaceuticals, Blueprint Medicines Corporation, Genentech USA, and AstraZeneca Pharmaceuticals.

ARS Pharmaceuticals, Inc. ARS Pharmaceuticals Receives FDA Approval to Remove Age Requirement From neffy® 1 mg (epinephrine nasal spray) Label. GlobeNewswire News Room. Published March 27, 2026. Accessed March 27, 2026. 

https://www.globenewswire.com/news-release/2026/03/27/3263722/0/en/ARS-Pharmaceuticals-Receives-FDA-Approval-to-Remove-Age-Requirement-From-neffy-1-mg-epinephrine-nasal-spray-Label.html

Campbell P. FDA Removes Age Requirement for Epinephrine Nasal Spray, Now Based on Weight Alone. HCPLive. March 27, 2026. Accessed April 9, 2026. 

https://www.hcplive.com/view/fda-removes-age-requirement-for-epinephrine-nasal-spray-now-based-on-weight-alone

Videos

Chase explains how the weight-based labeling update for epinephrine nasal spray (neffy) may improve access, adherence, and real-world use in young children.


Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Anaphylaxis

The HCPLive anaphylaxis page is a comprehensive resource for clinical news and insights on acute allergic reactions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for preventing anaphylaxis, and more.

FDA Removes Age Restriction for Epinephrine Nasal Spray, With Nicole Chase, MD

Anjali Vaidya, MD, is the director of the Advanced Pulmonary Hypertension, Right Heart Failure & CTEPH Program and the Pulmonary Hypertension Fellowship at Temple University Hospital and a professor of medicine at Temple University

The Mechanics Behind PAH Diagnosis and Management, With Anjali Vaidya, MD

In 2022, the European Society of Cardiology (ESC) released a set of comprehensive clinical guidelines for the detection and management of 

, emphasizing the importance of a multidisciplinary approach.

American College of Cardiology (ACC) Scientific Sessions 2026

 in New Orleans, Louisiana, Anjali Vaidya, MD, assistant dean at the Lewis Katz School of Medicine and director of advanced pulmonary hypertension, right heart failure, and the CETPH Program at Temple Health, spoke on the implementation of these guidelines. The editorial team at 

 met with Vaidya at the conference to learn more.

“The guidelines have evolved a lot over the years, which has been a wonderful thing to see,” Vaidya told 

. “But the inclusion of imaging modalities, and particularly electrocardiography, has really expanded in those guidelines. More and more advancement is being made, and more parameters are being included – I think we’ll continue to see that grow even further with the next iteration of guidelines.”

The ESC guidelines focus heavily on reanalyzing the hemodynamic definition of PAH. The authors officially updated the condition’s classification, repositioning vasoreactive patients with idiopathic PAH and developing a new algorithm for earlier detection of PAH in the community. The document also posits new, expedited screening and referral strategies.

Vaidya notes, however, that the most impactful aspect of the current guidelines is the emphasis on imaging in patients with PAH. Echocardiographic and cardiac magnetic resonance imaging (cMRI) parameters are proposed within the document, aiming to help clinicians monitor right ventricle function during the disease’s progression.

“The highest yield of imaging modality for pulmonary hypertension diagnosis is going to be echocardiography, or ultrasound of the heart, from an imaging perspective,” Vaidya said. “This is embedded in all of the pulmonary hypertension guidelines for diagnosis, and there are a lot of different parameters that can be interpreted to give us clues into the diagnosis of pulmonary hypertension.”

Vaidya also provides advice for clinicians entering the sphere of PAH management. She guides newcomers to make themselves familiar with the actual data of their patients rather than allowing technology to manage the numbers. Vaidya emphasizes the importance of being able to interpret data oneself to avoid mechanical errors or complications and to become more familiar with the condition and its effects.

“The most important thing is to practice and become comfortable with looking at the imaging directly rather than relying on reports,” Vaidya said. “There’s so much information available when you look at the pictures of cardiovascular structures, whether that’s on chest X-ray or CT scan or echocardiography, that is sometimes nuanced and subtle, so the biggest first step is to take a dive into it and open those images directly to become more and more comfortable with interpreting and not missing clues.”

Editors’ Note: Vaidya reports disclosures with Bayer, Janssen, Merck, and United Therapeutics.

Humbert M, Kovacs G, Hoeper MM, et al. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. European Heart Journal. 2022;43(38):3618-3731. 

Vaidya discusses the 2022 pulmonary arterial hypertension guidelines and how they can be made more accessible for clinicians just entering the field.

Cardiology

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Strategic Alliance Partnership

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.

The first quarter of 2026 brought meaningful progress across the hematology landscape, with new FDA approvals, updated clinical practice guidelines, and advancing pipeline therapies reshaping how clinicians approach rare and complex blood disorders. From the first-ever pediatric approval for acquired thrombotic thrombocytopenic purpura to landmark guideline updates in aplastic anemia, chronic kidney disease–related anemia, and AL amyloidosis, the quarter underscored a broader shift toward personalized, evidence-based care. 

Catch up on the coverage from the HCPLive editorial team with the key developments that defined Q1 2026 in hematology.

FDA Approves Caplacizuman-yhdp (Cavlivi) as First Pediatric aTTP Therapy

On January 5, 2026, the FDA approved caplacizumab-yhdp (Cablivi; Sanofi) for injection to treat pediatric patients aged ≥12 years with acquired thrombotic thrombocytopenic purpura, in combination with plasma exchange and immunosuppressive therapy. The decision builds upon caplacizumab’s initial 2019 approval for adults with aTTP.

The approval was supported by efficacy data from a retrospective chart review of 30 patients aged 2–18 years, in which 80% achieved clinical remission. Notably, the decision makes caplacizumab the first FDA-approved therapy for pediatric aTTP.

FDA Approves 2-Gram Presentation of Fibryga for Acquired Fibrinogen Deficiency

On January 7, 2026, the FDA approved a 2-gram presentation of fibrinogen (human) lyophilized powder for reconstitution (Fibryga) for fibrinogen replacement in patients with acquired fibrinogen deficiency. Fibryga is the first and only virus-inactivated, human plasma–derived fibrinogen concentrate approved for this indication in the US.

FDA Accepts New Drug Application for Rusfertide, Grants Priority Review In Polycythemia Vera

The acceptance of the NDA and grant of Priority Review for rusfertide to treat polycthemia vera was announced by Takeda and Protagonist on March 2, 2026.

According to the release, the decision was based on results from the phase 3 VERIFY, phase 2 REVIEW, and long-term extension THRIVE study, with the Prescription Drug User Fee Act (PDUFA) target action date set for the third quarter of this calendar year.1

ASH Releases 8 Recommendations for Relapsed, Refractory Acute Lymphoblastic Leukemia in Adolescents, Young Adults

New from ASH were 8 clinical recommendations and 1 research-only recommendation to guide management of relapsed or refractory acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs), emphasizing immunotherapy approaches.1

The 2026 Guidelines for Management of Relapsed/efractory ALL in AYAs underscore a paradigm shift toward immunotherapies, including blinatumomab and inotuzumab, over chemotherapy while reinforcing the importance of patient-informed, individualized clinical decision-making.

ASH Publishes Guidelines on Diagnosis and Management of Severe and Very Severe Acquired Aplastic Anemia

ASH has released updated guidelines outlining 33 recommendations and 4 good practice statements for the diagnosis and management of severe and very severe acquired aplastic anemia.

The guidance emphasizes improved diagnostic strategies, including expanded genetic testing, and supports personalized treatment approaches such as early use of eltrombopag alongside immunosuppressive therapy and timely transition to second-line options. Aimed at improving outcomes in this rare but life-threatening condition, the recommendations also seek to expand access to appropriate therapies and standardize care across patient populations.

KDIGO Releases New Guideline for Anemia in Chronic Kidney Disease

The 2026 KDIGO guideline update for the management of anemia in chronic kidney disease expands upon the prior 2012 guidance, with updated recommendations and practice points related to iron management, red blood cell (RBC) transfusions, and emerging therapies. The guideline incorporates new evidence intended to support individualized anemia management across the spectrum of CKD care.

ASH Releases New Clinical Practice Guidelines for Diagnosing AL Amyloidosis

, new clinical practice guidelines from ASH outline best practices to support clinicians in recognizing and diagnosing AL amyloidosis, a disease frequently missed or diagnosed late due to its heterogeneous presentation.

The panelists recommend blood and urine testing, including serum immunofixation, urine immunofixation, and serum free light chain assays, when clinical suspicion for AL amyloidosis exists. To confirm diagnosis, the panel supports the use of surrogate biopsies through combined bone marrow biopsy and abdominal fat pad sampling in most cases, while recognizing that target organ biopsies may be appropriate in select clinical scenarios.

Q1 2026 featured multiple inflection points in hematology spanning approvals, regulatory momentum, and major guideline revisions. Caplacizumab became the first FDA-approved option for pediatric aTTP (≥12 years) alongside plasma exchange and immunosuppression, supported by real-world remission data. A new 2‑g Fibryga presentation broadened fibrinogen replacement logistics for acquired deficiency. Rusfertide advanced toward potential approval in polycythemia vera under Priority Review. ASH and KDIGO issued updated, evidence-driven recommendations for relapsed/refractory AYA ALL, acquired aplastic anemia, CKD-related anemia, and earlier AL amyloidosis recognition.

Hematology

Q1 2026 Recap: Hematology News and Updates

The first quarter of 2026 marked a pivotal period in nephrology, with major regulatory decisions, guideline updates, and late-phase clinical trial readouts reshaping the treatment landscape for chronic kidney disease (CKD) and glomerular disorders. The US Food and Drug Administration advanced multiple high-impact therapies across focal segmental glomerulosclerosis (FSGS), IgA nephropathy (IgAN), and dialysis-related complications, including priority review for atacicept and continued evaluation of sparsentan and oxylanthanum carbonate. At the same time, the Kidney Disease: Improving Global Outcomes released its 2026 Clinical Practice Guideline for anemia in CKD, introducing updated recommendations on iron therapy, erythropoiesis-stimulating agents, and transfusion strategies, with an increased emphasis on individualized, symptom-driven care.

Parallel to these regulatory and guideline shifts, phase 2 and 3 trial data underscored continued momentum in precision nephrology and immunologic targeting. Studies such as TACITO, MAJESTY, and RAINIER highlighted emerging therapies ranging from microbiome-modulating strategies in kidney cancer to B-cell–targeted approaches and novel immunotherapies for proteinuric kidney diseases. Together, these developments reflect a rapidly evolving nephrology pipeline, with growing therapeutic diversity and a stronger focus on disease modification.

Beyond clinical and regulatory advances, thought leadership in the field continued to expand the conversation around kidney disease. Coverage this quarter explored the intersection of social determinants and CKD outcomes, as well as the accelerating pace of discovery in glomerular disease, reinforcing a broader shift toward holistic, patient-centered, and biologically driven care in nephrology.

Catch up on any of the FDA news, trial updates, and featured content you missed in Q1 2026.

FDA Extends Sparsentan (Filspari) sNDA Review for Focal Segmental Glomerulosclerosis

On January 13, 2026, the FDA announced its extended review of the supplemental New Drug Application (sNDA) for sparsentan (Filspari) to treat focal segmental glomerulosclerosis (FSGS). After the drug received a Major Amendment, the FDA moved the new PDUFA target action date to April 13, 2026

FDA Grants Priority Review Of Biologics License Application For Atacicept In IgA Nephropathy

for adults with IgAN received priority review of its Biologics License Application, supported by interim data analysis from ORIGIN 3, which met its primary endpoint of proteinuria reduction at week 36, with a 46% reduction compared to baseline, and a 42% reduction compared to placebo (

FDA Accepts Oxylanthanum Carbonate NDA Resubmission for Hyperphosphatemia in CKD, Dialysis

The FDA accepted Unicycive Therapeutics’ NDA for oxylanthanum carbonate (OLC) for the treatment of hyperphosphatemia in patients with CKD on dialysis on January 29, 2026. The Agency has deemed the OLC resubmission to be a Class II complete response, which has a 6-month review period from the date of resubmission. The PDUFA target action date is June 29, 2026.

On January 5, 2026, KDIGO Anemia Work Group released the 2026 Clinical Practice Guideline for the Management of 

 in CKD. Broken down into 4 main chapters, the first addresses the diagnosis and evaluation of anemia and iron deficiency in patients with CKD, including prevalence, pathophysiology, and clinical outcomes. The second focuses on iron therapy for anemia in CKD and prioritizes intravenous iron over oral formulations. The third chapter covers the use of erythropoiesis-stimulating agents and HIF-PHIs to raise hemoglobin, emphasizing shared decision-making and evaluation of alternative causes before treatment initiation. Lastly, the fourth outlines appropriate use of RBC transfusions, highlighting potential risks and recommending symptom-based assessment rather than hemoglobin thresholds alone.

TACITO: Fecal Microbiota Transplantation Improves Immunotherapy Response in Advanced Kidney Cancer

New evidence from the ​​phase 2a TACITO trial suggests FMT improves the effectiveness of immunotherapy in patients with advanced mRCC receiving pembrolizumab and axitinib, based on a hypothesis that transplanting favorable gut microbiome could enhance a patient’s response to immunotherapy.

MAJESTY: Obinutuzumab Achieves 2 Year Complete Remission in Primary Membranous Nephropathy

MAJESTY, the first global phase 3 study in primary membranous nephropathy (PMN), met its primary endpoint of complete remission at 2 years with obinutuzumab (Gazyva).

Genentech announced the positive 2-year phase 3 results of obinutuzumab compared to tacrolimus on February 16, 2026, with the potential for the therapeutic to become the first approved treatment for PMN.

RAINIER: Povetacicept Reduces Proteinuria By 52.0%

Povetacicept met its primary and secondary endpoints in RAINIER, an ongoing phase 3 trial evaluating adults with IgA nephropathy (IgAN), according to a 36-week interim analysis. Vertex Pharmaceuticals announced positive results where povetacicept showed a 52.0% reduction in urine protein to creatinine ratio (UPCR) compared to baseline, with a statistically significant and clinically meaningful 49.8% UPCR reduction compared to placebo (

Crisis Point: The Cause and Calamity, Neighborhood Disadvantage and Kidney Disease

Clinicians often thought of healthcare as having a problem and a solution, but this Crisis Point examined what was going on underneath the surface. With the rising threat of chronic kidney disease, more was at stake than the values measurable in a lab, this piece focused on the detrimental problem of neighborhood disadvantage as both the cause and the calamity of kidney disease.

ISGD and the Fastest 5 Years in Glomerular Disease

For experts from ISGD, the last 5 years were the fastest and most dynamic period in glomerular disease. In this special report, Barbara Gillespie, MD, an adult nephrologist at the University of North Carolina and Chief Medical and Strategy Officer at ISGD, and Toby Huber, MD, head of Internal Medicine at Hamburg-Eppendorf in Germany and founding president of ISGD, broke down the scientific advances and how they revolutionized biological understanding of glomerular diseases.

Q1 2026 delivered significant inflection points in nephrology across FSGS, IgA nephropathy, anemia of CKD, and dialysis-related mineral metabolism. Regulatory momentum included an extended FDA review timeline for sparsentan in FSGS, priority review for atacicept in IgAN, and a new PDUFA clock for oxylanthanum carbonate in dialysis hyperphosphatemia. KDIGO’s 2026 anemia guideline update sharpened recommendations around IV iron preference, judicious ESA/HIF-PHI use with shared decision-making, and symptom-based transfusion strategies. Late-phase readouts advanced immunologic and precision approaches, alongside increased attention to social determinants shaping CKD outcomes.

Catch up on nephrology headlines you missed from Q1 2026.

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.

Chronic Kidney Disease

IgA Nephropathy

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

FDA News

Q1 2026 Recap: Nephrology News and Updates

In this episode, ‘Hypercortisolism and Cardiovascular Risk Management,’ the panelists explore the broader implications of hypercortisolism on cardiovascular risk and the role of cardiologists in comprehensive patient management.

Video Series

Hypercortisolism and Cardiovascular Risk Management

This episode, titled ‘Hypercortisolism Treatment and Care Pathways,’ features panelists discussing the management of hypercortisolism following diagnosis, with a focus on the roles of cardiologists and endocrinologists in coordinating care. 

Hypercortisolism Treatment and Care Pathways

In ‘Hypertension Management in Hypercortisolism,’our panel explores the clinical implications of emerging data on hypercortisolism and outline a forward-looking approach to hypertension management.

Hypertension Management in Hypercortisolism

In this episode, ‘Hypercortisolism and Guideline Implications,’ the panelists explore the implications of emerging hypercortisolism data for clinical guidelines and routine cardiovascular practice.

Hypercortisolism and Guideline Implications

This episode, titled ‘Recognizing Hypercortisolism in Cardiology,’ features panelists discuss the clinical implications of emerging hypercortisolism data for cardiologists and how these findings should influence everyday practice. 

Recognizing Hypercortisolism in Cardiology

In ‘Hypercortisolism Hidden in Resistant Hypertension,’ our panel explored the design, findings, and clinical implications of the MOMENTUM study, a large, multicenter trial evaluating the prevalence of hypercortisolism in patients with resistant hypertension.

Hypercortisolism Hidden in Resistant Hypertension

In this episode, ‘Hypercortisolism and Difficult to Control Diabetes,’ the panelists explore the relationship between hypercortisolism and difficult-to-control diabetes, highlighting the role of excess cortisol as a key driver of metabolic dysfunction.

Hypercortisolism and Difficult to Control Diabetes

This episode, titled ‘Hypercortisolism in Resistant Diabetes and Cardiometabolic Disease,’ features panelists expanding the discussion of hypercortisolism beyond hypertension to include patients with poorly controlled or “resistant” diabetes, highlighting another high-risk population where cortisol excess may be underrecognized. 

Hypercortisolism in Resistant Diabetes and Cardiometabolic Disease

In ‘Evolving Hypercortisolism Screening and Diagnosis,’ our panel explored how emerging evidence is reshaping the approach to screening and diagnosing hypercortisolism in cardiovascular practice. 

Evolving Hypercortisolism Screening and Diagnosis

This episode explores how hypercortisolism extends beyond classic Cushingoid features, highlighting its variable presentation and role as a continuum of cortisol-driven cardiometabolic disease that is often underrecognized in clinical practice.

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