Regulatory
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According to Aridis Pharmaceuticals, the FDA has agreed to allow a Phase 2a trial of the company’s AR-501 nebulized formulation of gallium citrate for the treatment of lung infections in cystic fibrosis patients to skip… Read more . . .
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Esketamine (Spravato) and sumatriptan (Tosymra) nasal sprays are among the latest set of product specific draft guidances published by the FDA. Earlier this year, the agency published a product specific guidance for sumatriptan nasal powder.… Read more . . .
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The FDA has approved Lupin’s generic version of Teva’s ProAir HFA albuterol MDI for the treatment of asthma, the company said. Lupin said that it will manufacture the inhaler at its facility in Indore, India.… Read more . . .
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The FDA has accepted a supplemental NDA for United Therapeutics’s Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), the company said. In February 2020, United Therapeutics announced… Read more . . .
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The FDA has cleared an IND for NeuroRx to conduct a clinical trial of an inhaled formulation of its RLF-100 aviptadil in patients with moderate or severe COVID-19, the company said. NeuroRx recently announced that… Read more . . .
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Atossa Therapeutics said that it has gotten the go-ahead for a Phase 1 clinical study of its AT-301 nasal spray, which the company is developing for the treatment of COVID-19, and expects to begin enrollment… Read more . . .
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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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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