Regulatory
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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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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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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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Milestone Pharmaceuticals announced that the European Medicines Agency has accepted the company’s marketing application for its etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT), with a decision expected in early 2027. If approved, the… Read more . . .
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GH Research announced that the FDA has lifted a clinical hold on the company’s IND for GH001 inhaled mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression and that initiation of a Phase 3 trial is… Read more . . .
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The Chinese National Medical Products Administration (NMPA) has approved a 2 mg dose of ARS Pharmaceuticals’s neffy epinephrine nasal spray for the treatment of anaphylaxis in patients who weigh 30 kg or more, the company said.… Read more . . .
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According to Savara, the company has resubmitted its BLA for Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) with a request for priority review. Molbreevi has been granted Breakthrough Therapy and Fast Track… Read more . . .
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According to Asia Scientific Global, the FDA has cleared an IND that will allow a Phase 1 trial of its Beta1 inhaled dry powder therapy for the treatment of erectile dysfunction to move forward, and… Read more . . .
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Savara has announced two new European patents covering Molbreevi molgramostim inhalation solution. The company said that it has received notification from the European Patent Office that it intends to grant a patent covering the liquid… Read more . . .
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October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden
October 21-October 22: MVIC Symposium, Lund, Sweden
October 28-October 30: Deutches Aerosol Therapie Symposium (DATS), Marburg, Germany
November 10-November 11: Rescon Europe 2026, Porto, Portugal