Regulatory
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According to Boehringer Ingelheim, the United Kingdom, Croatia, Slovakia, Denmark, Norway, Ireland, Austria, Romania and Spain have approved the Spiolto Respimat tiotropium/olodaterol SMI for the treatment of COPD. BI recently announced the launch of the… Read more . . .
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The Canadian Agency for Drugs and Technology in Health (CADTH) has issued a call for patient input regarding GSK’s Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment of asthma. According to the announcement, the agency… Read more . . .
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The Israeli Patent Office has issued Patent No. 193318, “System for Pulmonary Delivery of Alpha-1 Proteinase Inhibitor,” to Kamada and PARI Pharma, Kamada has announced. The patent relates to delivery of Kamada’s inhaled alpha-1 proteinase… Read more . . .
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Impax Specialty Pharma has received approval from the FDA to market Zomig zolmitriptan nasal spray for the treatment of migraine in patients 12-17 years of age, the company says. Impax acquired the US rights to… Read more . . .
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According to United Therapeutics, the company has received notice that Watson Laboratories, a subsidiary of Allergan, has submitted an Abbreviated New Drug Application (ANDA) for a generic version of United Therapeutics’ Tyvaso treprostinil inhalation solution.… Read more . . .
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Adapt Pharma has initiated a rolling NDA submission for intranasal naloxone for the treatment of opioid overdose, the company said. Adapt licensed the intranasal naloxone formulation from Lightlake Therapeutics in December 2014 and received Fast… Read more . . .
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According to Boehringer Ingelheim, the FDA has approved its tiotropium bromide/olodaterol soft mist inhaler for the treatment of COPD. The company filed an NDA for the product, which will be marketed as Stiolto Respimat Inhalation… Read more . . .
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Advanced Inhalation Therapies (AIT) has announced that its AIT-CF high dose inhaled formulation of nitric oxide (NO) for the treatment of cystic fibrosis has been granted orphan medical product designation by the European Commission. In… Read more . . .
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The FDA has approved GSK’s supplemental NDA for the Breo Ellipta fluticasone furoate/vilanterol DPI, allowing GSK to market the inhaler for the treatment of asthma in patients aged 18 years and older. Breo Ellipta was… Read more . . .
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Aptar Pharma has announced that the Chinese State Food and Drug Administration (SFDA) has issued the company an import license for its preservative-free multi-dose opthalmic and nasal devices in accordance with regulations that require “Examination… Read more . . .
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