December 29, 2025
2 min read
Healio Pulmonology has compiled the top news from the FDA posted in 2025.
The top FDA pulmonology story from this year focused on the FDA’s draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform similarly in individuals with different skin pigments.
The top FDA pulmonology story from this year focused on the release of its draft guidance on recommendations for studies assessing pulse oximeters. Source: Adobe Stock
Additionally, this year the FDA approved the first treatment for idiopathic pulmonary fibrosis in more than 10 years, as well as the first treatment for non-cystic fibrosis bronchiectasis.
Read these and more of the most-read FDA pulmonology stories of 2025 below.
FDA releases draft guidance on pulse oximeter study recommendations
Thomas Valley
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform similarly in individuals with different skin pigments, according to a press release. Also, Thomas Valley, MD, MSc, associate professor of medicine at University of Michigan, shares his Perspective. Read more.
FDA-cleared AI-powered lung sound detection tool brings specialist to primary care, home
The FDA has granted clearance to TytoCare’s AI-powered Tyto Insights for Lung Sounds to detect rhonchi, marking the third lung sound alongside wheeze and crackles to receive the designation, according to a press release. Read more.
FDA approves nerandomilast for idiopathic pulmonary fibrosis
Amy Hajari Case
The FDA granted approval to nerandomilast, now Jascayd (Boehringer Ingelheim), for treating adults with IPF, marking the first treatment approved for this indication in more than 10 years, according to a notice from FDA. Also, Amy Hajari Case, MD, FCCP, chief medical officer of the Pulmonary Fibrosis Foundation and director of the ILD program and pulmonary and critical care research department at Piedmont Healthcare, shares her Perspective. Read more.
FDA updates Winrevair indication in PAH, highlighting impact in high-risk patients
Mohammed Andaleeb Chowdhury
The FDA approved a label update for Winrevair (sotatercept, Merck) to include that it lowers the risk for clinical worsening events in adults with advanced pulmonary arterial hypertension, according to a press release from Merck. Also, Mohammed Andaleeb Chowdhury, MD, assistant professor of medicine at the Lewis Katz School of Medicine at Temple University, shares his Perspective. Read more.
FDA updates Airsupra prescribing information to include benefit in mild asthma
The FDA has updated the prescribing information for Airsupra (Avillion, AstraZeneca), a fixed dose of albuterol and budesonide, to include that it lowers the risk for severe asthma exacerbations vs. albuterol alone in mild asthma, according to a press release. Read more.
FDA approves brensocatib for non-cystic fibrosis bronchiectasis
The FDA granted approval to brensocatib (Brinsupri, Insmed) for treating adults and children aged at least 12 years with non-cystic fibrosis bronchiectasis, marking the first treatment approved for this indication, according to a press release from Insmed. Read more.
FDA approves mepolizumab for COPD with eosinophilic phenotype
Mike Hess
The FDA granted approval to mepolizumab for treating adults with inadequately controlled COPD and an eosinophilic phenotype, according to a GSK press release. Also, Mike Hess, MPH, RRT, RPFT, senior director of advocacy and regulatory affairs at the COPD Foundation, shares his Perspective. Read more.
FDA clears investigational new drug application for lorundrostat in OSA, hypertension
The FDA approved the phase 2 Explore-OSA trial set to assess the highly selective aldosterone synthase inhibitor, lorundrostat (Mineralys Therapeutics), in adults with obstructive sleep apnea and hypertension, according to a press release. Read more.
FDA grants priority review to oral non-small cell lung cancer drug
The FDA granted priority review to a new drug application for sunvozertinib as an oral treatment for certain patients with locally advanced or metastatic non-small cell lung cancer, according to a press release from Dizal. Read more.
FDA grants fast track designation to CS1 for pulmonary arterial hypertension
The FDA granted fast track designation to oral histone deacetylase inhibitor CS1 for treating patients with PAH, according to a press release from Cereno Scientific. Read more.
Perspective
Overall, I agree these are among the most significant pulmonology-related FDA stories. There is a good breadth of topics, and this year, there have been several new FDA posts related to pulmonology.
I think the pulse oximetry study guidance and the approvals of nerandomilast and brensocatib are particularly important and stand out. They are either practice-changing approvals or, in the case of the pulse oximetry guidance, something that can shift some of the standard perceptions on assessing oxygenation status.
Lijo C. Illipparambil, MS, MD
Disclosures: Illipparambil reports no relevant financial disclosures.
Sources/Disclosures
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