News
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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 . . .
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Nuance Pharma has announced that the Phase 3 ENHANCE-CHINA study of nebulized ensifentrine in patients with COPD has met its primary endpoint. The company obtained the rights to ensifentrine, a PDE3/PDE4 inhibitor, in China, Macau, Taiwan,… Read more . . .
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According to Ritedose Pharmaceuticals, the FDA has approved an ANDA for the company’s generic albuterol sulfate inhalation solution, 0.5%. In April 2023, Ritedose announced that it had begun manufacturing 5 mg/ml albuterol sulfate inhalation solution… Read more . . .
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Lupin has announced a new partnership with Honeywell and said that it will use Honeywell’s Solstice Air HFO-1234ze, a low global warming potential (LGWP) propellant, in Lupin metered dose inhalers. The announcement did not specify… Read more . . .
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Rein Therapeutics (formerly Aileron Therapeutics) has announced the initiation of the Phase 2 RENEW trial of LTI-03, an inhaled dry powder caveolin-1 scaffolding domain peptide. The company had announced plans for the study in January 2025… Read more . . .
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AstraZeneca announced the that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the company’s marketing application for a reformulated Trixeo (Breztri) Aerosphere budesonide / glycopyrronium / formoterol fumarate that uses Honeywell’s Solstice Air HFO-1234ze as… Read more . . .
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Aptar CSP Technologies has announced an expansion of its cGMP manufacturing capacity for clinical packaging of dry powder inhalation capsules using the company’s Activ-Blister technology. Aptar CSP cited growing demand for the technology for both… Read more . . .
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3P innovation has announced that it is now offering new filling technology in its custom-built DPI filling systems that is based on equipment originally patented by GSK for high-speed filling of Diskus dry powder inhalers.… Read more . . .
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LTR Pharma announced a development agreement with Strategic Drug Solutions, Inc. for development of a nasal spray for the treatment of esophageal motility disorders (difficulty in swallowing). The Australian company says that the product will… Read more . . .
Upcoming Events
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May 10-May 14: RDD 2026, Phoenix, AZ, USA
May 15-May 16: ATS Respiratory Innovation Summit 2026, Orlando, FL, USA
May 17-May 20: ATS International Conference 2026, Orlando, FL, USA
June 9-June 10: Nasal Drug Delivery Symposium: Current Status and Future Opportunities, Stockholm, Sweden
June 10: SMI.London 2026, London, UK