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This FDA News Month in Review provides a round-up of regulatory decisions from February 2025.

Dupilumab improved R5–R20 and AX compared to placebo, possibly explaining improvements in disease control.

In this quiz, we test your knowledge of the latest guideline recommendations for aspirin therapy in AERD.

In this quiz, we examine your knowledge of biologic therapy for the treatment of CRSwNP.

In this quiz, we test your knowledge of evidence-based use of intranasal corticosteroids for patients with CRSwNP.

The regulatory agency has set a PDUFA target action date of August 27, 2025, for the investigational gene therapy.

Afif El-Hasan, MD of Kaiser Permanente in California joins host Albert Rizzo, MD, to discuss the acute effects of wildfire smoke on air quality.

Three subgroup analyses of the phase 3 NAVIGATOR study are set to be presented at the AAAAI/WAO Joint Congress.

Chalmers discussed how brensocatib’s potential approval may transform the currently empty treatment landscape for bronchiectasis.

Boehringer plans to soon submit a new drug application for nerandomilast for treating PPF to the FDA.

Our top 5 headlines include a trial of gene-edited pig kidneys, a first-of-its-kind antibiotic approval, and new guidelines for migraine.

Approved under the name Dupixent in September 2024, the biologic is the first of its kind approved for COPD.

Brensocatib, also a potential first-in-class DPP1 inhibitor, has a PDUFA date of August 12, 2025.

Despite being aware of its value in treating asthma, specialists were uncertain about integrating ITT into patient care.


In a Q&A, Kang discusses the role of MAVS in host resilience, aging as a contributing factor of lung disease, and the link between viral innate immunity and aging biology.

This pulmonology month in review highlights recent research on diagnosing asthma and new pivotal trial data.

This FDA News Month in Review provides a round-up of regulatory decisions and submissions from January 2025.

Merck announced robust efficacy data on the benefit of sotatercept for PAH in the STELLAR and ZENITH studies led to a loss of clinical equipoise in HYPERION.

Frevecitinib is a novel inhaled dry powder therapeutic in development for asthma that remains inadequately controlled by SOC inhaled maintenance therapies.

The study also revealed a predominant T2-low asthma endotype in majority Puerto Rican and Black or African American youth populations.

Race-Neutral Approach to Pulmonary Function Testing with Meredith McCormack, MD, and Loretta Que, MD
This month’s Lungcast features a discussion on pulmonary function tests and the controversial practice of using race-based normal values.

However, subgroup analyses may reveal a more pronounced effect in people with severe COPD.

CRN declined from 23.2% to 13.1% between 2011 and 2022 but still affects around 2.5 million adults in the US.

New findings cast doubt on required black box warnings for montelukast (brand name Singulair).


































































