News
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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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According to Krystal Biotech, the FDA has granted regenerative medicine advanced therapy (RMAT) designation to the company’s KB707 inhaled gene therapy for the treatment of non-small cell lung cancer. The company notes that the designation… Read more . . .
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Israeli psychedelic drug developer Clearmind Medicine has signed an agreement with Polyrizon for development of an intranasal formulation of Clearmind’s 5‑methoxy‑2‑aminoindane (MEAI) based on Polyrizon’s intranasal hydrogel technology, the companies said. According to Clearmind, MEAI… 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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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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