Regulatory
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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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According to Kexing Biopharm, the FDA has approved the company’s IND for GB05 human interferon alpha-1b inhalation solution, which the company’s subsidiary Shenzhen Kexing plans to advance into clinical development for the treatment of lung… Read more . . .
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According to Cessatech, a positive notified body opinion has been issued under Article 117 of the Medical Devices Regulation for the company’s CT001 sufentanil / ketamine nasal spray. Cessatech says that it expects to submit… Read more . . .
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According to Kinaset Therapeutics, the FDA has cleared the company’s IND for a Phase 2b trial of its KN-002 frevecitinib dry powder inhaler. The 12-week Phase 2 trial, which will evaluate 3 doses of dry… Read more . . .
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Ocugen, Inc. announced that the FDA has cleared an IND for a Phase 1 trial of OCU500 vaccine for the prevention of COVID-19, which the company licensed from Washington University in St. Louis in 2022. The… Read more . . .
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Nevada-based Corstasis Therapeutics announced that the FDA has accepted the company’s NDA for RSQ-777 bumetanide nasal spray, a diuretic for the treatment of edema associated with congestive heart failure, kidney disease, and liver disease. The… Read more . . .
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According to Johnson & Johnson, the FDA has approved the company’s sNDA for Spravato esketamine nasal spray as a monotherapy for the treatment of major depressive disorder in adults who have not responded adequately to… Read more . . .
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Swedish pharma company Newbury Pharmaceuticals announced that its marketing application for Azelastine + Fluticasone Newbury, a generic version of Dymista azelastine / fluticasone nasal spray, has been approved by Norwegian regulators for the treatment of… Read more . . .
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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