Regulatory
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The FDA has granted orphan drug and rare pediatric disease designations to Spirovant Sciences’s SPIRO-2101, an inhaled adeno-associated virus (AAV) gene therapy for the treatment of cystic fibrosis, the company said. SPIRO-2101 works by replacing defective… Read more . . .
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Hikma Pharmaceuticals and Vectura announced that the FDA has issued a minor complete response letter regarding Hikma’s ANDA for VR315 fluticasone propionate/salmeterol DPI, a generic version of GSK’s Advair Diskus. The companies say that they… Read more . . .
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GlaxoSmithKline and Innoviva have announced that the Trelegy Ellipta fluticasone furoate / umeclidinium / vilanterol DPI has been approved by the FDA for the treatment of asthma in adult patients. The approved doses for the… Read more . . .
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Marinomed Biotech said that it has submitted an MAA via the decentralized marketing authorization procedure for a xylometazoline decongestant nasal spray formulated with the company’s Carragelose red algae extract. The company currently markets a range… Read more . . .
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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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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