Regulatory
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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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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 . . .
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