Regulatory
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The FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee met on February 12, 2019 to consider Janssen’s NDA for its esketamine nasal spray for the treatment of treatment-resistant… Read more . . .
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The FDA has cleared Pulmatrix’s investigational new drug application, giving the company the go-ahead to begin a Phase 2 clinical trial of Pulmazole (PUR1900) inhaled dry powder itraconazole for the treatment of allergic bronchopulmonary aspergillosis… Read more . . .
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AIT Therapeutics said that it has received a $3.15 million milestone payment from Circassia Pharmaceuticals after successful completion of a pre-submission meeting with the FDA for AirNOvent nitric oxide delivery system. Circassia recently announced that… Read more . . .
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The FDA announced that it has approved Mylan’s generic version of Advair Diskus fluticasone propionate/salmeterol DPI for the treatment of asthma in patients four years old and older and for the treatment of COPD. Three… Read more . . .
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Aradigm Corporation, which submitted an MAA for its dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa lung infections in non-cystic fibrosis bronchiectasis (NCFBE) patients in March 2018, has announced that it submitted… Read more . . .
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The FDA has approved Promius Pharma’s Tosymra sumatriptan nasal spray (formerly known as DFN-02) for the treatment of migraine, Promius parent company Dr. Reddy’s has announced. The company submitted an NDA for the nasal spray… Read more . . .
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FDA Commissioner Scott Gottlieb has issued a statement detailing steps that the agency is taking to encourage development of an over the counter naloxone nasal spray, including the publication of a model drug facts label… Read more . . .
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The FDA has approved Acorda’s Inbrija levodopa DPI for the treatment of OFF episodes in Parkinson’s disease patients taking carbidopa/levodopa, the company said. Inbrija is expected to be available to patients in the US in… Read more . . .
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According to Teva, the FDA has approved the company’s sNDA for ProAir Digihaler dry powder albuterol smart inhaler for the treatment or prevention of bronchospasm in patients aged 4 and over. The FDA initially approved… Read more . . .
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The European Commission has approved AstraZeneca’s Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of COPD, the company has announced. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion regarding… Read more . . .
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