Posted by Michael Wonder on 16 Apr 2026
Savara announces the US FDA has extended the review period for the molgramostim inhalation solution biologics license application in autoimmune pulmonary alveolar proteinosis
15 April 2026 - Savara today announced that the FDA has extended the review period for the molgramostim BLA in autoimmune PAP by three months.
The Agency is reviewing the molgramostim BLA under priority review and the new PDUFA target action date is 22 November 2026.
