Regulatory
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Nuance Pharma announced that the Hong Kong Drug Office has approved Ohtuvayre ensifentrine inhalation suspension for the treatment of COPD. According to Nuance, Ohtuvarye had been available through certain medical facilities in Macau and Hong Kong… Read more . . .
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Glenmark’s generic equivalent of FloVent HFA fluticasone propionate MDI gets final approval from FDA
According to Glenmark, the FDA has approved the company’s ANDA for a generic equivalent of GSK’s FloVent HFA fluticasone propionate MDI with competitive generic therapy (GGT) designation. FloVent HFA was initially approved in 2004, and… Read more . . .
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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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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 Savara, the FDA has accepted the company’s BLA for Molbreevi mogramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis. In March 2025, Savara announced that it had completed a rolling BLA submission… 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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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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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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October 21-October 22: MVIC Symposium, Lund, Sweden
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland