Regulatory
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The FDA is touting its June 1, 2021 approval of Sandoz’s ANDA for an albuterol sulfate MDI for the treatment of asthma, saying, “The FDA recognizes the increased demand for certain products during the COVID-19… Read more . . .
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According to Liquidia, the FDA has accepted the company’s resubmitted NDA for LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension and has set a PDUFA goal date of November 7, 2021. Liquidia initially… Read more . . .
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Inhaler monitoring company Adherium has submitted a 510(k) application for a new Hailie sensor designed to work with the Symbicort MDI the company announced. The company recently rejected a takeover bid from another Australian asthma… Read more . . .
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According to Lannett, the FDA has set a GDUFA goal date of January 31, 2022 for completion of its review of the ANDA for Respirent’s generic version of Advair Diskus fluticasone propionate / salmeterol DPI… Read more . . .
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The EMA’s COVID-19 task force has said “that there is currently insufficient evidence that inhaled corticosteroids are beneficial for people with COVID-19.” In addition, the task force said that “it could not exclude the possibility… Read more . . .
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The UK Ministry of Healthcare Products Regulatory Agency (MHRA) announced that it has approved an application from Aventis Pharma (Sanofi) to reclassify Nasacort Allergy Relief triamcinolone acetonide nasal spray for the treatment of allergic rhinitis in… Read more . . .
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Liquidia has announced the resubmission of its NDA for LIQ861 dry powder treprostinil for the treatment of pulmonary arterial hypertension, with the addition of CMC and device data requested by the FDA. Liquidia initially submitted… Read more . . .
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The FDA has approved a 505(b)(2) NDA for Hikma’s Kloxxado naloxone nasal spray for the reversal of opioid overdose. Hikma says that it expects to launch the nasal spray, which was approved for use in… Read more . . .
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Health Canada has approved Syqe Medical’s metered dose medical cannabis inhaler, the company said. The Syqe inhaler, which uses a cartridge pre-loaded with granulated cannabis, has been available to patients in Israel since June 2019.… Read more . . .
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Glenmark Pharmaceuticals said that it plans to launch Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of allergic rhinitis in 16 European Union countries and the UK after finalizing marketing approval. Menarini Group… 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