Medical
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SpliSense’s SPL84 inhaled antisense oligonucleotide for CF gets early PRIME designation from the EMA
According to SpliSense, the European Medicines Agency has granted early Priority Medicines designation to the company’s SPL84 inhaled antisense oligonucleotide for the treatment of cystic fibrosis in patients with a 3849+10Kb C>T mutation in the… Read more . . .
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A consortium called NOFLU has received €13 million from the European Health and Digital Executive Agency (HaDEA) under the EU4Health program to support development of an intranasal vaccine against influenza. The NOFLU consortium consists of… Read more . . .
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According to SoftOx Defense Solutions, the Irish Health Products Regulatory Authority has approved a clinical trial application for the company’s SIS-02 Phase 1 study of SIS hypochlorous acid inhalation solution in healthy volunteers. SoftOx recently… Read more . . .
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According to Gossamer Bio, the Phase 3 PROSERA trial of its seralutinib dry powder inhaler in patients with pulmonary arterial hypertension missed its primary endpoint of change in 6-minute walk distance from baseline. The company… Read more . . .
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Cyrano Therapeutics has announced that the Phase 2 FLAVOR trial of CYR-064 intranasal theophylline soft-mist spray for the treatment of hyposmia (loss of smell) following viral infection did not demonstrate any safety or tolerability concerns,… Read more . . .
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Qnovia announced that a Phase 1 trial of RespiRx inhaled nicotine, which is delivered via a handheld nebulizer, demonstrated that the nebulized formulation produced a Tmax comparable to cigarettes with lower plasma exposure. Qnovia had… Read more . . .
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MannKind Corporation has announced the initiation of the Phase 2 INHALE-1ST trial of Afrezza inhaled dry powder insulin in children aged 10 and over who have recently received a diagnosis of Type 1 diabetes. The study… Read more . . .
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Pulmovant announced that the Phase 2 PHocus clinical trial of its inhaled dry powder mosliciguat in patients with pulmonary hypertension due to interstitial lung disease (PH-ILD) has completed enrollment, and the company expects to report… Read more . . .
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Leyden Labs has published results from pre-clinical and clinical studies of its PanFlu (CR9114) intranasal antibody in the journal Science Translational Medicine. According to the company, two Phase 1 trials that enrolled a total of 143… Read more . . .
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ENA Respiratory has announced the initiation of the Phase 2 POSITS trial of its INNA-051 once-weekly antiviral nasal powder. In April 2025, ENA announced that researchers at the University of Maryland would conduct a Phase… Read more . . .
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