Regulatory
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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 . . .
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The European Commission has approved Chiesi’s Trimbow Nexthaler extrafine beclometasone dipropionate / formoterol fumarate / glycopyrronium DPI for the treatment of moderate to severe COPD in patients not adequately treated with an ICS/LABA or LABA/LAMA… Read more . . .
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Hikma Pharmaceuticals said that the FDA has approved an amendment to the company’s ANDA for its generic version of Advair Diskus fluticasone propionate / salmeterol DPI, and the company has subsequently restarted the launch of… Read more . . .
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United Therapeutics said that it has submitted an NDA for its Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and has applied a priority review voucher that it acquired for $105 million… Read more . . .
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According to Teva Pharmaceuticals Europe, the company has received marketing authorization in the EU for duplicate DPIs Seffalair Spiromax salmeterol xinafoate/ fluticasone propionate and BroPair Spiromax salmeterol xinafoate/ fluticasone propionate for the treatment for asthma… Read more . . .
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Respirent has submitted an ANDA to the FDA for its fluticasone propionate / salmeterol xinafoate DPI in 100/50 μg, 250/50 μg, and 500/50 μg dose levels for the treatment of asthma and COPD, according to… Read more . . .
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According to United Therapeutics, the FDA has approved Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). Tyvaso has been approved for the treatment of pulmonary arterial hypertension… Read more . . .
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The UK National Institute for Health Research has designated the PROTECT-V trial of Union Therapeutics’ UNI91103 niclosamide nasal spray for the treatment of COVID-19 in kidney patients as an Urgent Public Health (UPH) priority, the… 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
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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