Regulatory
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According to Circassia Pharmaceuticals, the FDA has approved the company’s sNDA for the addition of data from the Phase 4 ASCENT study of the Tudorza Pressair aclidinium bromide DPI in COPD patients showing significant reduction… Read more . . .
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The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) will meet on May 8, 2019 to consider Chiesi’s NDA for Bronchitol mannitol DPI for the treatment of cystic fibrosis. According to Bronchitol developer Pharmaxis, its partner Chiesi… Read more . . .
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The FDA announced that it has approved Janssen’s NDA for Spravato esketamine nasal spray for the treatment of treatment-resistant depression. Spravato is to be used with an oral antidepressant and distribution will restricted under a… Read more . . .
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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 . . .
Upcoming Events
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October 21-October 22: MVIC Symposium, Lund, Sweden
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland