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Autoimmune-Summaries: Daily Autoimmune Updates at a Glance

  • Ashish Shukla, PhD
  • 17 hours ago
  • 1 min read

15/04/2026












Savara announced that the US FDA had extended the review period for molgramostim BLA in autoimmune PAP (Ref)


Savara announced that the FDA had extended the review period for the malgramostim (Molgramostim Inhalation Solution) BLA in autoimmune pulmonary alveolar proteinosis (Autoimmune PAP) by three months


  • The Agency was reviewing the molgramostim BLA under Priority Review and the new PDUFA target action date was set for  November 22, 2026


  • The agency did not cite any safety, efficacy, or manufacturing concerns in their correspondence.


  • This extension allows the FDA additional time to complete their review of the BLA, including recently submitted materials related to information requests



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