Pulmonology in 2025: Year in Review

Pulmonology in 2025 was defined by long-awaited regulatory breakthroughs that expanded treatment options across some of the field’s most persistent areas of unmet need. FDA approvals spanned eosinophilic airway disease, fibrotic lung disorders, rare neoplastic conditions, and bronchiectasis, signaling a shift from symptom control toward disease modification, precision targeting, and less burdensome dosing strategies.

Biologics and immunotherapies continued to reshape care paradigms, with approvals such as mepolizumab for eosinophilic COPD and depemokimab-ulaa for severe asthma reinforcing biomarker-driven treatment across traditionally siloed diseases. At the same time, nerandomilast’s approval marked the first new therapy for idiopathic pulmonary fibrosis in more than a decade, while brensocatib became the first disease-modifying option for non–cystic fibrosis bronchiectasis—both milestones for patient populations long underserved by innovation.

Beyond approvals, 2025 also delivered important signals from trials, post hoc analyses, and updated guidelines that refined how clinicians think about airway inflammation, lung function, and exacerbation risk. Mixed late-stage data in COPD, emerging antifibrotic strategies, and renewed emphasis on guideline-based care made up a year of progress and recalibration, pointing pulmonology toward a more nuanced, trait-based, and patient-centered future.

FDA News

FDA Approves Mepolizumab for Eosinophilic COPD

On May 22, the FDA has approved mepolizumab (Nucala) as an add-on maintenance treatment for patients with COPD with an eosinophilic phenotype. In the phase 3 MATINEE trial, mepolizumab demonstrated a statistically significant and clinically meaningful 21% reduction in the annualized rate of moderate or severe exacerbations (0.80 events per year) compared to placebo (1.01 events per year; rate ratio, 0.79; 95% CI, 0.66 to 0.94; P = .01), successfully meeting the primary endpoint.

FDA Approves Depemokimab-ulaa (Exdensur) for Severe Asthma

The FDA has approved GSK’s depemokimab-ulaa (Exdensur) as an add-on maintenance therapy for severe eosinophilic asthma in patients aged 12 years and older, introducing the first ultra–long-acting biologic in this space with twice-yearly dosing. The approval was supported by data from the phase 3 SWIFT-1 and SWIFT-2 trials demonstrating significant reductions inannualized asthma exacerbations compared with placebo while maintaining a safety profile comparable to standard of care.

Nerandomilast Nets First New FDA Approval for Idiopathic Pulmonary Fibrosis in Over 10 Years

The FDA has approved nerandomilast 9 mg and 18 mg (Jascayd; Boehringer Ingelheim) for adults with idiopathic pulmonary fibrosis, marking the first new IPF therapy approved in more than a decade. The decision was supported by phase 3 FIBRONEER-IPF data showing significantly reduced decline in forced vital capacity versus placebo, with a generally well-tolerated safety profile.

Zopapogene Imadenovec First Immunotherapy Approved for Recurrent Respiratory Papillomatosis

As of August 14, the FDA approved zopapogene imadenovec-drba (Papzimeos) for adults with recurrent respiratory papillomatosis, marking the first non-replicating adenoviral vector–based immunotherapy authorized for the disease. The decision was supported by phase 1/2 data showing a 51% complete response rate and substantial reductions in surgical interventions, with a generally well-tolerated safety profile.

FDA Approves First Bronchiectasis Therapy, Brensocatib, for Ages 12 and Up

As of August 12, the FDA approved brensocatib (Brinsupri) 10 mg and 25 mg for adults and adolescents aged 12 years and older with non–cystic fibrosis bronchiectasis, marking the first disease-modifying therapy for the condition. The decision was based on phase 3 ASPEN trial data showing a significant reduction in pulmonary exacerbations versus placebo, establishing a new treatment option targeting neutrophilic inflammation in this historically underserved disease.

Trial Updates and New Guidelines

Tezepelumab Fails Study Endpoint of Reducing Moderate-to-Severe COPD Exacerbations

Tezepelumab was not seen to reduce the annualized rate of moderate or severe COPD exacerbations, thus failing the primary endpoint of COURSE, a phase 2a trial (NCT04039113). Singh and colleagues found that the annualized rate of moderate or severe COPD exacerbations represented a nonsignificant change and thus did not meet the trial’s primary endpoint.

Genentech (Roche)’s Astegolimab Shows Mixed Data for COPD

Genentech reported mixed phase 3 results for astegolimab in COPD, with the ALIENTO trial showing a statistically significant 15.4% reduction in annualized exacerbation rate at 52 weeks, while the ARNASA trial failed to meet its primary endpoint despite a similar 14.5% reduction. Neither trial found no new safety signals, but the inconsistent efficacy results may challenge astegolimab’s regulatory path.

Taladegib Shows Potential to Improve FVC in Idiopathic Pulmonary Fibrosis

Taladegib (ENV-101) demonstrated a favorable safety profile and promising signals of efficacy in a phase 2a proof-of-concept trial in patients with idiopathic pulmonary fibrosis. Treatment was associated with improvements from baseline in forced vital capacity and multiple HRCT-based measures of fibrosis, supporting further clinical development in an area of ongoing unmet need.

Nerandomilast Meets Primary Endpoint in Improving FVC in Progressive Pulmonary Fibrosis

The FDA has approved nerandomilast (Jascayd) for adults with idiopathic pulmonary fibrosis, marking the first new IPF treatment approved in more than a decade. The oral PDE4B inhibitor demonstrated a significant slowing of lung function decline with a favorable safety profile in phase 3 trials, expanding therapeutic options for a disease with substantial unmet need.

Dupilumab Improves Small Airway Dysfunction in People With Type 2 Asthma

Dupilumab improved small airway dysfunction (SAD) among a population with type 2 high moderate-to-severe asthma, which could explain improvements in disease control, according to a post hoc analysis of the Phase 4 VESTIGE study presented at the 2025 AAAAI/WAO Joint Congress. Those treated with dupilumab reported significant improvements in SAD as measured by peripheral airway resistance and compliance.

Feature Content/Podcasts

Rewriting Airway Disease With Trait-Based Care: 2025’s Convergence of Asthma and COPD Management

In this HCPLive expert discussion moderated by Joseph Khabbaza, MD, clinicians examine how the FDA approval of mepolizumab for eosinophilic COPD could mark a turning point in a field long limited to symptom-focused therapies. Drawing on phase 3 MATINEE data, the panel highlights its potential to reduce exacerbations, limit systemic steroid exposure, and usher COPD care toward a more asthma-like, biomarker-driven precision model.

Going for GOLD: Updated COPD Guidelines with Gerard Criner, MD

COPD continues to pose a substantial global and US health burden, prompting updated 2024 GOLD guidelines that sharpen guidance on diagnosis, comorbidity management, and evidence-based care. In this Lungcast episode, Gerard Criner, MD, breaks down key updates, including renewed emphasis on spirometry, smoking cessation, pulmonary rehabilitation, and cardiovascular risk, highlighting how GOLD translates evolving science into practical, patient-centered recommendations.

The Biologic Era in COPD: What Mepolizumab Approval Means for Exacerbation Control
In this HCPLive expert discussion moderated by Joseph Khabbaza, MD, clinicians examine how the FDA approval of mepolizumab for eosinophilic COPD could mark a turning point in a field long limited to symptom-focused therapies. Drawing on phase 3 MATINEE data, the panel highlights its potential to reduce exacerbations, limit systemic steroid exposure, and usher COPD care toward a more asthma-like, biomarker-driven precision model.

Getting Through the Door: How COPD, Lung Cancer Screening Remains Minimal

Despite well-established screening tools and expanded eligibility criteria, COPD and lung cancer remain profoundly underdiagnosed in the US, with most patients still identified at advanced stages when survival benefits are limited. Experts point to systemic access gaps, clinician hesitation, and persistent disease stigma as key barriers, underscoring that improving outcomes in 2026 will depend less on new technology than on using the tools already proven to work.