SVRA News & Events

Savara announced the FDA has filed for review the BLA for Molbreevi as a therapy to treat patients with autoimmune PAP. The FDA granted Priority Review with a PDUFA action date of August 22, 2026.

Savara announced the FDA has filed for review the BLA for Molbreevi as a therapy to treat patients with autoimmune PAP. The FDA granted Priority Review with a PDUFA action date of August 22.

Savara announced that it has resubmitted the Molbreevi BLA to the FDA, with Fujifilm as the drug substance manufacturer. The Molbreevi BLA submission is seeking approval for the treatment of autoimmune PAP, a chronic and debilitating rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. The company has requested Priority Review of the application.