Regulatory
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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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Aradigm Corporation says that it has scheduled a meeting with the FDA to discuss results from the Phase 3 ORBIT-3 and ORBIT-4 trials of Apulmiq (formerly Linhaliq) dual release inhaled ciprofloxacin for the treatment of… Read more . . .
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Insys Therapeutics says that it plans NDA submissions for both its naloxone and epinephrine nasal sprays in 2019. The company also noted the potential of regulatory submission for its inhaled dronabinol in the next few… Read more . . .
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Pharmaxis said that its distribution partner Methapharm Inc. has begun selling Pharmaxis’ Aridol mannitol bronchial challenge test kit again in the United States. According to the company, its Sydney, Australia manufacturing facility received FDA approval… Read more . . .
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Zambon has announced that its colistimethate sodium powder for nebulized delivery as a solution by the Philips i-neb nebulizer system, has received QIDP and fast track designations from the FDA for the prevention of exacerbations… Read more . . .
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According to Auris Medical, the FDA has granted orphan drug designation to its intranasal betahistine for the treatment of obesity associated with Prader-Willi syndrome (PWS). The company also said that it has signed a letter… Read more . . .
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Tiziana Life Sciences has announced that the FDA approved the company’s IND for intranasal foralumab human anti-CD3 antibody, and a Phase 1 clinical trial has begun. Tiziana licensed foralumab from Novimmune in 2014 and is… Read more . . .
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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