Regulatory
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According to Tiziana Life Sciences, the FDA has cleared the company’s IND to allow clinical development of intranasal foralumab in Alzheimer’s disease. Earlier this year, Tiziana announced plans to develop foralumab, an intranasal anti-CD3 monoclonal antibody,… Read more . . .
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Marinomed Biotech said that its partner M8 Pharmaceuticals has received marketing authorization for Carragelose iota-carrageenan nasal spray in Mexico. M8 acquired the rights to market the nasal spray in Mexico and Brazil in 2021. According… Read more . . .
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Defender Pharmaceuticals announced that it has submitted an NDA for its DPI-386 scopolamine nasal gel for the prevention of motion sickness in adults. According to the company’s web site, Defender has worked with the US… Read more . . .
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The FDA announced that it has approved Harm Reduction Therapeutic’s NDA for RiVive naloxone nasal spray for the reversal of opioid overdose. Harm Reduction initiated a rolling NDA submission for RiVive in October 2022, and… Read more . . .
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Liquidia Corporation announced that it has submitted an sNDA for its Yutrepia treprostinil DPI, which was tentatively approved by the FDA in November 2021 for the treatment of pulmonary arterial hypertension (PAH). The supplemental application is… Read more . . .
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According to Lupin, the company’s generic version of Boehringer Ingelheim’s Spiriva Handihaler tiotropium bromide DPI has been approved for the treatment of COPD by Australia’s Therapeutic Goods Administration (TGA). Lupin said that it will manufacture… Read more . . .
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The FDA has approved Padagis’s supplemental application for over-the-counter sales of the company’s generic version of Narcan naloxone nasal spray, 4 mg, for the reversal of opioid overdose. Padagis initially launched its generic in the… Read more . . .
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Health Canada announced that Pharmascience’s Pendopharm division is recalling one lot of Rhinaris Nasal Mist saline nasal spray after “testing showed that the preservative in the product may not be as effective as expected.” Specifically,… Read more . . .
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According to Lupin, the FDA has approved the company’s ANDA for a generic version of Par Pharmaceutical’s Nascobal single dose cyanocobalamin nasal spray. Lupin said that it will manufacture the nasal spray at its plant… Read more . . .
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Lupin announced that the FDA has approved the company’s ANDA for its generic of Boehringer Ingelheim’s Spiriva HandiHaler tiotropium bromide inhalation powder. Health Canada approved the company’s tiotropium DPI earlier this year. In the UK,… Read more . . .
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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
October 21-October 22: MVIC Symposium, Lund, Sweden
October 28-October 30: Deutches Aerosol Therapie Symposium (DATS), Marburg, Germany
November 10-November 11: Rescon Europe 2026, Porto, Portugal