Regulatory
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Evoke Pharma said that it has received a multi-disciplinary review letter from the FDA regarding its NDA for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis in adult women. According to Evoke, the letter… Read more . . .
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The FDA has issued a new product-specific guidance for dihydroergotamine mesylate nasal spray and revised guidances for fluticasone propionate; azelastine hydrochloride/fluticasone propionate; mometasone furoate; and triamcinolone acetonide nasal sprays since February 1, 2019. According to… Read more . . .
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Aradigm Corporation, which recently announced that it has filed for bankruptcy, said that it held a Type B meeting with the FDA on January 25, 2019 at which the agency expressed continued concerns about data… Read more . . .
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ARS Pharmaceuticals said that the FDA has granted Fast Track designation to its ARS-1 intranasal epinephrine, which is in development for the treatment of anaphylaxis. In December 2018, the company announced that it had raised… Read more . . .
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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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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