Regulatory
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VistaGen Therapeutics said that the FDA has agreed to details of a proposed Phase 3 trial of the company’s PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD). PH94B was granted Fast Track… Read more . . .
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Health Canada has issued a Notice of Compliance for Janssen Pharmaceutical’s Spravato esketamine nasal spray for the treatment of major depressive disorder, and the product is now available to Canadian patients, the company said. Spravato… Read more . . .
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According to the UK’s Medicines & Healthcare products Regulatory Agency (MHRA), Ferring Pharmaceuticals has recalled multiple batches of Desmospray 0.1 mg/ml desmopressin, Aspire branded desmopressin 0.1 mg/ml, and Octim desmopressin 1.5 mg/ml nasal sprays “due… Read more . . .
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Novartis’s Enerzair Breezhaler (QVM149) indacaterol / glycopyrronium / mometasone furoate DPI has been approved by the EC for the treatment of asthma, the company said. The inhaler can now be marketed with an optional Propeller… Read more . . .
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The Japanese Ministry of Health, Labour and Welfare has approved two Novartis DPIs — Enerzair Breezhaler glycopyrronium / indacaterol/ mometasone furoate and Atectura indacaterol / mometasone furoate — for the treatment of asthma, the company… Read more . . .
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Over a dozen well-known OINDP specialists have issued a call for accelerated development of inhaled therapies for COVID-19, with the goal of getting these products to patients faster. Writing to the editor of the Journal… Read more . . .
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The FDA has approved Evoke Pharma’s Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis, the company said. Evoke originally submitted an NDA for Gimoti in in June 2018 and acknowledged receipt of a complete response… Read more . . .
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DPI developer TFF Pharmaceuticals said that the FDA has granted orphan drug designation to its dry powder tacrolimus for the prevention of lung transplant rejection. The company also said that it plans to initiate a… Read more . . .
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United Therapeutics has filed a patent infringement suit against Liquidia Technologies in the US District Court for the District of Delaware alleging infringement of US patents 9,604,901 and 9,593,066, which protect Tyvaso treprostinil inhalation solution. Both patents… Read more . . .
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The FDA has issued new and revised product-specific guidances (PSGs) for a number of OINDPs as of June 3, 2020. The agency also updated its list of planned PSGs for complex generics, adding a number… Read more . . .
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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