Q4 2025 Recap: Pulmonology News and Updates

Pulmonology news in Q4 2025 was anchored by meaningful regulatory and clinical advances across asthma and pulmonary fibrosis, underscoring a continued shift toward longer-acting, anti-inflammatory, and disease-modifying strategies. FDA approvals of depemokimab-ulaa for severe eosinophilic asthma and nerandomilast for idiopathic pulmonary fibrosis marked major milestones for patient populations long constrained by limited therapeutic options, while emerging phase 2 data for taladegib suggested that momentum in antifibrotic development may be accelerating beyond a single new agent.

At the same time, late-2025 data and expert discussions highlighted how evolving evidence is reshaping real-world care. Label expansion of albuterol/budesonide into mild asthma, dramatic reductions in oral corticosteroid use with tezepelumab, and renewed focus on trait-based management across asthma and COPD reflected a broader effort to reduce exacerbations and treatment burden earlier in disease. Yet alongside these advances, persistent gaps in COPD and lung cancer screening served as a reminder that progress in pulmonology will depend not only on innovation, but on consistent application of tools already shown to improve outcomes.

Check out this recap of what made headlines in Q4 of 2025:

FDA News

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.

FDA Expands Albuterol/Budesonide Label to Adults With Mild Asthma

On October 1, 2025, AstraZeneca announced FDA approval of a supplemental new drug application for albuterol/budesonide (Airsupra), expanding its indication to include adults with mild asthma. Based on results from the phase 3b BATURA trial, the therapy reduced the risk of severe exacerbations by nearly half compared with albuterol and lowered annual systemic steroid use, while maintaining a favorable safety profile. The update builds on prior evidence from the MANDALA and DENALI trials, further supporting Airsupra as the first anti-inflammatory rescue option across asthma severities.

New Investigations

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.

Tezepelumab Drastically Reduces OCS Use for Asthma in Open-Label Trial

Nearly all patients with severe, OCS-dependent asthma in the WAYFINDER trial were able to lower their daily steroid dose to 5 mg or less after 52 weeks of open-label tezepelumab, and half fully discontinued OCS while maintaining asthma control. These improvements were consistent across inflammatory subgroups, though the absence of a control arm makes the magnitude of benefit harder to interpret.

Deeper Dives

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.

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.