Regulatory
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Vero Biotech has announced that the FDA will allow expanded access to the company’s Genosyl DS tankless inhaled nitric oxide (iNO) delivery system so that it can be used for the treatment of cardiopulmonary symptoms of… Read more . . .
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The PAP Foundation, a US organization that advocates for pulmonary alveolar proteinosis (PAP) patients, says that it supports FDA approval of Savara’s Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). The group said that it… Read more . . .
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Nephron Pharmaceuticals CEO Lou Kennedy spoke to local reporters in the company’s home state of South Carolina on March 17, 2020, describing the company’s efforts to increase production of its inhalation solutions and suspensions to… Read more . . .
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Insmed has announced its submission of a new drug application to Japan’s Ministry of Health, Labour and Welfare (MHLW) for Arikayce amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium… Read more . . .
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Beyond Air said that it has submitted an investigational device exemption (IDE) to the FDA seeking to use its cylinder-free LungFit BRO inhaled nitric oxide (iNO) delivery system for the treatment of COVID-19. Beyond Air has been developing… Read more . . .
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Functional respiratory imaging (FRI) company Fluidda announced that the FDA has cleared the company’s Broncholab FRI platform for use in clinical settings. According to the company, Broncholab can provide much more accurate information about patient-specific… Read more . . .
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According to Senzer, the company has obtained the IND application and data package for its inhaled dronabinol from its former partner, Insys Therapeutics, and will now move ahead with development for the treatment of side… Read more . . .
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The FDA has announced the publication of a batch of new and revised product specific guidances for development of generic versions of a number of drugs, including a number of inhaled and nasal drug products,… Read more . . .
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Virpax Pharmaceuticals has announced the successful completion of a pre-IND meeting with the FDA regarding the company’s NES100 intranasal enkephalin formulation for the management of acute and chronic pain. NES100 is a molecular envelope technology… Read more . . .
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GSK and Innoviva have announced that the EMA accepted a regulatory submission to expand the use of Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI to add the treatment of asthma in adults as an indication. Trelegy Ellipta… 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