Regulatory
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Theravance Biopharma and Mylan have announced that the NDA for revefenacin (TD-4208) inhalation solution for the treatment of COPD the companies submitted in November 2017 has been accepted for review by the FDA, with a… Read more . . .
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Aradigm Corporation has received a complete response letter from the FDA in response to its NDA for Linhaliq dual release inhaled ciprofloxacinfor the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients, the… Read more . . .
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According to GlaxoSmithKline and Innoviva, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding approval of the Relvar Ellipta fluticasone furoate/vilanterol DPI for the treatment of asthma that… Read more . . .
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The Icelandic Medicines Agency has approved an MAA filed by Medical Developments International (MVP) to allow marketing of Penthrox inhaled methoxyflurane for the treatment of pain due to traumatic injury. The company said that Penthrox… Read more . . .
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Aradigm Corporation said that the FDA’s Antimicrobial Drugs Advisory Committee (ADAC) has voted against approval of the company’s NDA for Linhaliq dual release inhaled ciprofloxacin for the treatment of P. aeruginosa lung infections in non-cystic… Read more . . .
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Generic DPI device developer Merxin has announced that its MRX003 capsule based dry powder inhaler has received CE marking certification. The inhaler, which was launched in May 2017, is designed for generic tiotropium products submitted… Read more . . .
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Savara has submitted an investigational new drug application for Molgradex inhaled recombinant human GM-CSF for the treatment of autoimmune pulmonary alveolar proteinosis (PAP) to the FDA, the company said. In May 2017, the company said… Read more . . .
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A citizen petition filed by Mylan on December 5, 2017 asks the FDA not to approve any ANDA for a generic version of Advair Diskus that relies on data from multiple-batch PK bioequivalence studies “unless,… Read more . . .
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The FDA said in a Drug Safety Communication that it has approved the removal of Boxed Warnings about asthma-related deaths from ICS/LABA combination inhalers. The inhalers affected by the change are Advair Diskus, Advair HFA,… Read more . . .
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Medical Developments International (MVP) has announced that the Decentralized Procedure for its Penthrox methoxyflurane inhaler marketing application has been completed, and the inhaler has been approved in an additional 22 countries. Penthrox has been available… 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
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