Regulatory
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Adapt Pharma has submitted an NDA for Narcan naloxone nasal spray for the treatment of opioid overdose to the FDA, the company has announced. In June 2015, Adapt said that it had initiated a rolling… Read more . . .
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Propeller Health has received 510(k) clearance from the FDA to market the Propeller inhaler monitoring platform for use with the Diskus DPI and with the Respimat SMI, the company announced. Two versions of the Propeller… Read more . . .
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The FDA has approved Amneal Pharmaceuticals’s generic version of Tobi tobramycin inhalation solution, the company said. The product is the New Jersey-based generic pharmaceutical company’s first inhalation solution. Amneal co-CEO and Chairman Chirag Patel said,… Read more . . .
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The FDA has issued product-specific recommendations for demonstrating the bioequivalence of over 40 drug products, including several OINDPs. The newly added documents include guidances for azelastine HCL/fluticasone propionate nasal spray, budesonide/formoterol fumarate MDI, and levalbuterol… Read more . . .
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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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October 21-October 22: MVIC Symposium, Lund, Sweden
October 28-October 30: Deutches Aerosol Therapie Symposium (DATS), Marburg, Germany
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland