News
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According to AlveoGene, the FDA has granted orphan drug designation to the company’s AVG-002 inhaled gene therapy for the treatment of neonatal surfactant protein B deficiency. AVG-002 also recently received rare pediatric disease designation for that… Read more . . .
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CDMO Hovione has announced the completion of expansion projects at its facilities in East Windsor, NJ, USA and Ringaskiddy, Cork, Ireland that its says will provide a significant increase in the company’s spray drying capacity and will… Read more . . .
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According to Satsuma Pharmaceuticals and its parent company Shin Nippon Biomedical Laboratories, the FDA has accepted the company’s resubmitted NDA for STS101 dihydroergotamine nasal powder for the treatment of migraine and has set a PDUFA… Read more . . .
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Blue Lake Biotechnology and CyanVac reported that a Phase 2a clinical trial of their CVXGA intranasal vaccine against SARS-CoV-2 demonstrated that participants who received CVXGA had a 78% lower risk of symptomatic infection one month… Read more . . .
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Virpax Pharmaceuticals announced the extension of a research and development agreement with an institute of the National Institutes of Health (NIH) related to the company’s NES100 enkephalin nasal spray for the treatment of acute and… Read more . . .
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The ALS Association, which supports research on amyotrophic lateral sclerosis, has awarded a grant to Tiziana Life Sciences to support a clinical trial of intranasal foralumab in 20 patients with ALS at Massachusetts General Hospital,… Read more . . .
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Nocion Therapeutics has announced the initiation of the Phase 2b ASPIRE clinical trial of its NOC-110 inhaled dry powder taplucainium (formerly NTX-1175) in patients with chronic cough. Earlier this year, the company said that it… Read more . . .
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NurExone Biologic announced that the EMA has granted orphan medicinal product designation to NurExone’s ExoPTEN intranasal exosome therapy, which the company is developing for the treatment of spinal cord injury. In 2023, the FDA granted orphan drug… Read more . . .
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AlveoGene’s AVG-002 inhaled gene therapy gets rare pediatric disease designation for SP-B deficiency
UK-based start-up AlveoGene announced that its AVG-002 nebulized gene therapy for neonatal surfactant protein B (SP-B) deficiency has received a rare pediatric disease designation from the FDA. The company says that it will advance AVG-002… Read more . . .
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Pulmatrix has announced a planned merger with biopharma Cullgen, which is developing oral protein degraders for the treatment of various indications. In anticipation of the merger, Pulmatrix says that it will divest inhalation assets, including… Read more . . .
Upcoming Events
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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
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden