Regulatory
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Lupin announced that the Drug Controller General of India approved the company’s Vilfuro-G vilanterol / fluticasone furoate / glycopyrronium bromide dry powder inhaler for the treatment of COPD, and the company has launched the DPI… Read more . . .
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The United States Federal Trade Commission (FTC) announced that it has challenged the Orange Book listings of more than 100 patents related to combination products, with most of those patents related to inhaler device components… Read more . . .
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According to Acorda Therapeutics, Biopas Laboratories has submitted marketing applications for Inbrija levodopa inhalation powder for the treatment of OFF episodes in Parkinson’s disease in Argentina, Colombia, Costa Rica, Ecuador, Panama, and Peru. In May 2022,… Read more . . .
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According to Syqe Medical, Australia’s Therapeutic Goods Administration (TGA) has approved the company’s SyqeAir cannabis inhaler, which includes 60 metered doses of milled cannabis flowers. The cartridge-based inhaler will now appear in the Australian Register… Read more . . .
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According to AstraZeneca, the FDA has accepted for review the company’s supplemental biologics license application (sBLA) for self-administration of FluMist Quadrivalent nasal spray vaccine against influenza. AstraZeneca says that it expects a PDUFA date in the… Read more . . .
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Milestone Pharmaceuticals said that it has submitted an NDA for its etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) and that the FDA has conditionally approved the proposed trade name “Cardamyst.” The company… Read more . . .
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According to Tiziana Life Sciences, the FDA is allowing patients with multiple sclerosis who are taking part in an expanded access program through Brigham and Women’s Hospital to use intranasal foralumab at home instead of… Read more . . .
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Aculys Pharma says that it plans to move ahead with submission of a marketing application to Japanese authorities based on interim data showing that a Japanese Phase 3 clinical study of NRL-1 diazepam nasal spray… Read more . . .
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GH Research announced that the FDA has placed a clinical hold on an IND that the company submitted for GH001 inhaled mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression, citing “Insufficient information to assess risks… Read more . . .
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According to Defender Pharmaceuticals, the FDA has accepted the company’s NDA for DPI-386 scopolamine nasal gel for the treatment of motion sickness for priority review, with a PDUFA goal date of January 26, 2024. Defender… Read more . . .
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