Regulatory
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According to Corstasis Therapeutics, the FDA has approved the company’s NDA for Enbumyst (RSQ-777) bumetanide nasal spray for the treatment of edema associated with heart, kidney, and liver disease. In January 2025, Corstasis announced that… Read more . . .
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According to Pulmovant, the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation to Pulmovant’s inhaled dry powder mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).… Read more . . .
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Australian inhaled drug developer InhaleRx announced that it has received approval from the Bellberry Human Research Ethics Committee for a Phase 1 trial of its IRX-616a MDI, which the company is developing for the treatment… Read more . . .
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According to BiomX, the FDA has placed a clinical hold on the company’s recently-initiated Phase 2b trial of BX004 inhaled phage cocktail in cystic fibrosis patients with chronic P. aeruginosa lung infections. BiomX said that the… Read more . . .
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Proveca and Cessatech have announced the submission of a pediatric-use marketing authorization (PUMA) application for CT001 sufentanil / ketamine nasal spray for the treatment of pain in pediatric patients and said that the EMA has… Read more . . .
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According to Tiziana Life Sciences, the FDA has approved the company’s IND for a Phase 2a trial of intranasal foralumab in patients with multiple system atrophy (MSA). The company is currently developing intranasal foralumab for the… Read more . . .
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According to AstraZeneca, the EMA’s the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding the company’s LGWP version of Trixeo (Breztri) Aerosphere budesonide / glycopyrronium / formoterol MDI, which uses Honeywell’s Solstice… Read more . . .
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HCmed Innovations announced that the FDA has granted 510(k) clearance to the company’s AdheResp connected breath-actuated mesh nebulizer, which delivers aerosol during inhalation only. According to the company, AdheResp is the first nebulizer of its… Read more . . .
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According to ARS Pharmaceuticals, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the company’s marketing application for EURneffy adrenaline nasal spray for the emergency treatment of anaphylaxis in patients who weigh more than 30… Read more . . .
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Hong Kong-based Guangdong Hengrui Pharmaceuticals’s parent company Jiangsu Hengrui Pharmaceuticals announced that Guangdong Hengrui has received approval from the Chinese National Medical Products Administration (NMPA) for a clinical trial of its HRS-9821 DPI, which the… 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