Regulatory
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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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Milestone Pharmaceuticals says that it completed a Type A meeting with the FDA and subsequently submitted its response to the agency’s complete response letter regarding Milestone’s NDA for Cardamyst etripamil nasal spray for the treatment of… Read more . . .
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According to Savara, the FDA has issued an RTF letter in response to the company’s BLA for Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP), citing insufficient CMC data. Savara completed… Read more . . .
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At the end of March 2025, the FDA accepted Liquidia Corporations’s resubmitted NDA for Yutrepia dry powder treprostinil for inhalation for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung… 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