Also known as: recombinant human granulocyte-macrophage colony-stimulating factor
Savara has submitted a Biologics License Application for MOLBREEVI to the FDA with Priority Review status, targeting an August 22, 2026 decision date for treating autoimmune pulmonary alveolar proteinosis.
The FDA has filed Savara's biologics license application for MOLBREEVI to treat autoimmune pulmonary alveolar proteinosis, granting Priority Review with a target action date of August 22, 2026.
Savara Inc. announced the FDA has filed for review the BLA for MOLBREEVI to treat autoimmune PAP, granting Priority Review with a PDUFA action date of August 22, 2026. The therapy could become the first approved treatment for this rare lung disease.
Savara Inc. announced the FDA has accepted its resubmitted Biologics License Application for MOLBREEVI, a treatment for autoimmune pulmonary alveolar proteinosis, with Priority Review granted and a target decision date of August 22, 2026.
