Regulatory
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The FDA has approved Janssen Pharmaceutical’s sNDA for the expanded use of Spravato esketamine CIII nasal spray for the treatment of major depressive disorder with acute suicidal ideation or behavior, the company said. Spravato was initially approved… Read more . . .
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AstraZeneca has announced that its Breztri Aerosphere (PT010) budesonide / glycopyrrolate / formoterol fumarate MDI has been approved by the FDA for the treatment of COPD. The FDA had previously issued a complete response letter… Read more . . .
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According to Insmed, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding approval of the company’s Arikayce nebulized liposomal amikacin for the treatment of non-tuberculous mycobacterial (NTM) lung… Read more . . .
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Milestone Pharmaceuticals said that it has raised $25 million from RTW Investments in a private placement and indicated that the proceeds would be sufficient for company operations through the second quarter of 2022. The company… Read more . . .
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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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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
December 9-December 11: DDL 2026, Edinburgh, Scotland