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The FDA has approved Aridol (mannitol inhalation powder, from Pharmaxis) Bronchial Challenge Test Kit for the assessment of bronchial hyperresponsiveness in patients ≥6 years of age who do not have clinically apparent asthma.

Aerovance Inc. announced top-line results from its Phase 2b trial demonstrating that Aerovant (pitrakinra) is effective in a pre-defined subset of patients with eosinophilic asthma.

The FDA has finalized label revisions for both single ingredient and combination long-acting beta-agonist-containing respiratory medications for the treatment of asthma.

Asthmatx announced that the FDA has approved the Alair Bronchial Thermoplasty System for the treatment of severe persistent asthma in patients ≥18 years of age whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists, the current standard-of-care treatment for these patients.

Merck announced results from two Phase 3 studies investigating fixed-dose combinations of mometasone furoate and formoterol fumarate (MF/F) for the management of asthma, for which a New Drug Application (NDA) is currently under review by the FDA.

The FDA announced that long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma.

Forest Laboratories and Glenmark Pharmaceuticals announced top-line results from a Phase 2b dose range-finding study of oglemilast in patients with Chronic Obstructive Pulmonary Disease (COPD).

The FDA is evaluating interim safety findings from the ongoing EXCELS study of Xolair (omalizumab subcutaneous injection, from Genentech and Novartis), that suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair compared to the control group of patients not given the drug.