Regulatory
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Vistagen announced that it has received a “study may proceed” letter from the FDA in response to the company’s IND for a Phase 2 trial of refisolone nasal spray for the treatment of hot flashes caused… Read more . . .
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Savara has announced that the FDA is giving itself extra time to review the company’s BLA for molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis, setting November 22, 2026 as the new… Read more . . .
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ARS Pharmaceuticals and ALK announced that Canadian regulators have approved a 2 mg dose of neffy epinephrine nasal spray for the treatment of anaphylaxis in adults and children who weigh at least 30 kg. The… Read more . . .
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According to Savara, the MHRA has accepted the company’s marketing application for Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis for accelerated review, with a decision expected by the end of… Read more . . .
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ARS Pharmaceuticals announced that the FDA has approved an sNDA to remove the age requirement for the 1 mg dose of neffy epinephrine nasal spray for the treatment of anaphylaxis. A 2 mg dose of… Read more . . .
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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 molgramostim 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 . . .
Upcoming Events
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July 13-July 16: 2026 ISAM Congress, Taipei, Taiwan
September 15-September 18: DDL New Researcher Network Summer Event, London, UK
September 16-September 17: IPAC-RS 2026 Nasal Innovation Forum, Jersey City, NJ, USA
September 24-September 25: Inhaled & Nasal Biologics | DNA Forum, Cambridge, UK
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