Regulatory
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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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The FDA has announced the approval of Perrigo’s ANDA for a generic of Teva’s ProAir HFA albuterol MDI for the treatment of asthma in patients 4 years old and older. Perrigo initially filed its ANDA for… Read more . . .
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The FDA has approved Teva’s ArmonAir Digihaler fluticasone propionate DPI for the treatment of asthma in patients aged 12 and older, the company said. ArmonAir Respiclick was approved for that indication in January 2017. Three doses… Read more . . .
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Koura (formerly Mexichem Fluor) announced that the FDA has cleared the company’s IND for Zephex HFA 152a MDI propellant, and the company plans to initiate clinical trials of the propellant this month. In December 2019,… 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 10: SMI.London 2026, London, UK
July 13-July 16: 2026 ISAM Congress, Taipei, Taiwan