Regulatory
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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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Evoke Pharma announced that it has received a notice of allowance from the United States Patent and Trademark Office (USPTO) for a continuation of US Patent No. 11,517,545 (“Treatment of Moderate and Severe Gastroparesis”), which was issued… Read more . . .
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According to Theravance Biopharma, a marketing application submitted to the Chinese National Medical Products Administration (NMPA) by Viatris for Yupelri revefenacin inhalation solution for the treatment of COPD has been approved. In November 2023, Theravance and Viatris announced… Read more . . .
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GH Research announced that it has submitted its response to a clinical hold of an IND for the company’s GH001 inhaled mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression. The FDA cited “Insufficient information to… Read more . . .
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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
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden
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