August 2012
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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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According to ALK, the EMA’s Committee for Medicinal Products for Human Use has recommended approval of a 1 mg dose of EURneffy adrenaline nasal spray for the treatment of anaphylaxis in children who weigh between 15 kg… 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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NMPA accepts Nuance’s NDA for Ohtuvayre ensifentrine inhalation suspension for the treatment of COPD
According to Nuance Pharma, China’s National Medical Products Administration has accepted the company’s NDA for Ohtuvayre inhaled ensifentrine for the treatment of COPD. Nuance announced in May 2025 that the Phase 3 ENHANCE-CHINA study of nebulized ensifentrine… Read more . . .
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Transpire Bio has announced the FDA’s acceptance of the company’s ANDA for a generic version of GSK’s Trelegy Ellipta fluticasone furoate / umeclidinium / vilanterol dry powder inhaler. The company says that it believes that it… Read more . . .
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Milestone Pharmaceuticals’ Cardamyst etripamil nasal spray is now available in US pharmacies, and a national sales campaign is expected to begin within the next few weeks, the company said. The FDA approved Cardamyst for the… Read more . . .
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According to GSK, the Chinese National Medical Products Administration (NMPA) has approved 100/62.5/25 mcg and 200/62.5/25 mcg strengths of Trelegy Ellipta fluticasone furoate / umeclidinium / vilanterol DPI for the treatment of adult patients with asthma. The… Read more . . .
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Copley Scientific, which introduced its new dissolution testing apparatus for OINDPs at DDL 2025, has announced the official launch of the Inhaled Dissolution Apparatus (IDA). The company points out that many developers of generic inhaled… Read more . . .
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Rein Therapeutics announced that the EMA has granted orphan drug designation to the company’s LTI-03 inhaled dry powder caveolin-1 scaffolding domain peptide for the treatment of idiopathic pulmonary fibrosis. LTI-03 already has orphan designation from… Read more . . .
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