Regulatory
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The FDA has announced that it approved Eli Lilly and Company’s Baqsimi single-use intranasal dry powder glucagon for the emergency treatment of severe hypoglycemia. Lilly announced that it had submitted the NDA for Baqsimi in… Read more . . .
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The FDA has issued a final guidance titled “Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff” that specifies how to comply with postmarketing safety reporting (PMSR) requirements for combination products issued in 2016.… Read more . . .
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Penthrox methoxyflurane inhaler maker Medical Developments International said that it recently met with the FDA regarding the agency’s August 2018 clinical hold letter on Penthrox, and the company now has a path forward to resolve… Read more . . .
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Aridis Pharmaceuticals said that the EMA has granted orphan drug designation to the company’s AR-501 inhaled gallium citrate for the treatment of pulmonary infections in cystic fibrosis patients. The company said that the FDA had… Read more . . .
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The FDA has approved low, medium, and high dose versions of Teva’s AirDuo Digihaler fluticasone propionate/salmeterol digital DPI for the treatment of asthma, the company said. The inhaler should be available in the US sometime next… Read more . . .
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Insys Therapeutics, which recently filed for bankruptcy, said that the FDA has accepted its NDA for the company’s single unit dose naloxone nasal spray. In December 2018, Insys said that it planned to submit NDAs… Read more . . .
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Glenmark Pharmaceuticals has revealed that the FDA issued a complete response letter to the company’s NDA for Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray. The agency accepted the NDA for Ryaltris in August 2018 with a… Read more . . .
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According to Syqe Medical, the company has received regulatory approval from the Israeli Ministry of Health to launch its metered-dose cannabis inhaler in Israel for the treatment of pain. The inhaler, which was previously available only… Read more . . .
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The Japanese Ministry of Health, Labour and Welfare has approved AstraZeneca’s Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of COPD, the company said. Bevespi Aerosphere has been approved for the treatment of COPD in the US since… Read more . . .
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The Brazilian Health Regulatory Agency (ANVISA) has approved Afrezza inhaled insulin for the treatment of diabetes, and the DPI is expected to be launched in Brazil by the end of 2019, MannKind Corporation said. MannKind announced… 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