News
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AtaiBeckley said that it completed an End‑of‑Phase 2 meeting with the FDA regarding BPL‑003 intranasal mebufotenin for the treatment of treatment‑resistant depression (TRD) and that the agency indicated that it supports the company’s plan for… Read more . . .
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US biopharm Esperion will pay $75 million in cash up front and up to $180 million in milestone payments to acquire Corstasis Therapeutics and its Enbumyst bumetanide nasal spray, the companies said. The deal also… Read more . . .
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According to Pulmatrix, Cullgen has terminated the 2024 merger agreement between the companies. Pulmatrix said that it would In December 2025, Pulmatrix and Cullgen announced that Chinese authorities had still not approved the merger, 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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A consortium called NOFLU has received €13 million from the European Health and Digital Executive Agency (HaDEA) under the EU4Health program to support development of an intranasal vaccine against influenza. The NOFLU consortium consists of… 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 Gossamer Bio, the Phase 3 PROSERA trial of its seralutinib dry powder inhaler in patients with pulmonary arterial hypertension missed its primary endpoint of change in 6-minute walk distance from baseline. The company… Read more . . .
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Iconovo announced that it has signed a letter of intent with CDMO Lonza related to development of spray dried formulation of inhaled biologics. The companies announced in January 2025 that Lonza would develop spray dried… 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 . . .
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Cyrano Therapeutics has announced that the Phase 2 FLAVOR trial of CYR-064 intranasal theophylline soft-mist spray for the treatment of hyposmia (loss of smell) following viral infection did not demonstrate any safety or tolerability concerns,… 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