Regulatory
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Johnson & Johnson said that it has submitted an sNDA to the FDA for the use of Spravato esketamine CIII nasal spray as a monotherapy for the treatment of treatment-resistant depression. In 2019, the FDA approved… Read more . . .
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The FDA has issued a complete response letter to Orexo’s NDA for OX124 intranasal dry powder naloxone for the reversal of opioid overdose, the company said. Orexo resubmitted the NDA in September 2023 after the… Read more . . .
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According to NeOnc Technologies, the FDA has approved an expansion of an ongoing Phase 2a trial of the company’s NEO100 intranasal perillyl alcohol to include patients with recurrent grade 3 astrocytoma with isocitrate dehydrogenase 1… Read more . . .
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ARS Pharmaceuticals announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding the company’s MAA for the European version of its Neffy epinephrine nasal spray. In April… Read more . . .
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Tiziana Life Sciences announced that it will dose a patient with moderate Alzheimer’s disease with intranasal foralumab under an expanded access IND. The company previously used the expanded access program to provide intranasal foralumab to… Read more . . .
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According to Verona Pharma, the FDA has approved the company’s NDA for Ohtuvayre (ensifentrine, RPL554), a PDE3/PDE4 inhibitor delivered via jet nebulizer, for the treatment of COPD. Verona submitted the NDA for ensifentrine in June… Read more . . .
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OBG subsidiary Ayrton Saunders announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a Type II variation to the 2014 marketing authorization for the Voke nicotine inhaler, which is approved for… Read more . . .
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According to Agomab Therapeutics, the company’s AGMB-447 inhaled ALK5 inhibitor has received orphan drug designation from the FDA for the treatment of idiopathic pulmonary fibrosis (IPF). Agomab initiated a Phase 1 trial of AGMB-447 in… Read more . . .
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According to Liquidia Corporation, a judge in the US District Court for the District of Delaware has denied a United Therapeutics motion seeking a preliminary injunction to prevent Liquidia from launching Yutrepia treprostinil DPI for the treatment… Read more . . .
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Milestone Pharmaceuticals announced that the FDA has accepted the company’s NDA for Cardaymyst etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone originally submitted the NDA in October 2023, and the FDA issued a… Read more . . .
Upcoming Events
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October 21-October 22: MVIC Symposium, Lund, Sweden
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland