Regulatory
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Vectura Group and Sosei Group each said that they are owed $2.5 million milestone payments from Novartis after the EU accepted Novartis’s MAA for its QVM149 indacaterol/glycopyrronium/mometasone furoate DPI for the treatment of asthma that… Read more . . .
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The FDA has approved an ANDA for Akorn’s generic azelastine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis in patients 5 years old and older and for vasomotor rhinitis in patients 12 and… Read more . . .
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UCB said that the FDA has approved an NDA for Nayzilam midazolam nasal spray (formerly USL261) for the treatment of seizure clusters in epilepsy patients aged and older. UCB acquired the nasal spray from former… Read more . . .
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The FDA’s Pulmonary‐Allergy Drugs Advisory Committee (PADAC) has voted to recommend approval of Chiesi’s NDA for Bronchitol DPI for the treatment of cystic fibrosis in adult patients. According to Bronchitol developer Pharmaxis, Chiesi re-submitted the… Read more . . .
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According to Glenmark Pharmaceuticals, the Russian Ministry of Healthcare has approved the company’s Momate Rhino mometasone furoate nasal spray for over-the-counter sales for the treatment of allergic rhinitis in adults. Glenmark Pharmaceuticals Senior VP and… Read more . . .
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The FDA has announced the final approval of Teva’s ANDA for a generic naloxone hydrochloride nasal spray. According to the announcement, the agency tentatively approved the ANDA in June 2018. Opiant Pharmaceutical’s Narcan nasal spray… Read more . . .
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Akorn announced that the FDA has approved an ANDA for fluticasone propionate nasal spray submitted by Hi Tech Pharmacal, which was acquired by Akorn in 2014. The nasal spray is a generic of GSK’s Flonase,… Read more . . .
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According to Synspira Therapeutics, the company’s SNSP113 inhaled glycopolymer for the treatment of cystic fibrosis has received orphan drug desination from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP). The FDA granted… Read more . . .
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According to Evoke Pharma, the FDA has issued a complete response letter in response to the company’s NDA for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis. The PDUFA date for completion of… Read more . . .
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The FDA has approved Duaklir Pressair aclidinium bromide/formoterol fumarate DPI for the treatment of COPD, Circassia Pharmaceuticals has announced. Circassia said in August 2018 that the FDA had accepted the NDA for Duaklir and an… Read more . . .
Upcoming Events
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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
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden