Regulatory
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Milestone Pharmaceuticals announced that it has received a complete response letter from the FDA in regard to the company’s NDA for Cardamyst etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone first submitted… Read more . . .
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Savara announced that it has completed its BLA submission for Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The company had announced the initiation of the rolling submission in December 2024.… Read more . . .
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Vast Therapeutics announced that its ALX1 inhalation solution for the treatment of lung infections has received Qualified Infectious Disease Product designation from the FDA. The company describes ALX1 as a nitric oxide pro-drug, and the… Read more . . .
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According to ReCode Therapeutics, the FDA has granted orphan drug designation to the company’s RCT2100 inhaled mRNA therapy for the treatment of cystic fibrosis in patients who do not benefit from CFTR modulators. In February… Read more . . .
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French biotech Lovaltech announced that the Agence nationale de sécurité du médicament (ANSM) and the Comité de Protection des Personnes (CPP) have authorized the company’s planned MUCOBOOST Phase 1 trial of LVT-001 nasal vaccine against… Read more . . .
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According to Emergent BioSolutions, Health Canada has approved Hikma Pharmaceuticals’ Kloxxado naloxone nasal spray 8 mg for the treatment of opioid overdose. In January 2025, Emergent announced that it was acquiring US and Canadian rights to… Read more . . .
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According to Xlear, the US Department of Justice has asked a US District Court judge to dismiss a suit filed by the US Federal Trade Commission in 2021 accusing the company of violating the COVID-19… Read more . . .
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Oragenics announced that it has submitted an Investigator’s Brochure application to Australian authorities seeking the go-ahead for a Phase 2 trial of ONP-002, a dry powder intranasal neurosteroid, for the treatment of mild traumatic brain… Read more . . .
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Tiziana Life Sciences announced that it has submitted an IND to the FDA seeking approval for a Phase 2 trial of intranasal foralumab in patients with amyotrophic lateral sclerosis. In November 2024, the company announced… Read more . . .
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Taipei-based inhaled drug developer Asia Scientific Global announced that it has completed a pre-IND meeting with the US FDA regarding its Beta 1 dry powder inhaler, a PDE-5 inhibitor that the company is developing for… Read more . . .
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September 24-September 25: Inhaled & Nasal Biologics | DNA Forum, Cambridge, UK