Regulatory
-
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 . . .
-
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 . . .
-
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 . . .
-
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 . . .
-
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 . . .
-
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 . . .
-
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 . . .
-
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 . . .
-
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 . . .
-
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
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
May 10-May 14: RDD 2026, Phoenix, AZ, USA
May 15-May 16: ATS Respiratory Innovation Summit 2026, Orlando, FL, USA
May 17-May 20: ATS International Conference 2026, Orlando, FL, USA
June 9-June 10: Nasal Drug Delivery Symposium: Current Status and Future Opportunities, Stockholm, Sweden
June 10: SMI.London 2026, London, UK