FDA accepts Savara’s MOLBREEVI BLA for priority review in autoimmune PAP

Reuters
Yesterday
FDA accepts Savara’s MOLBREEVI BLA for priority review in autoimmune PAP

Savara Inc. said the U.S. Food and Drug Administration has filed for review its Biologics License Application for MOLBREEVI to treat autoimmune pulmonary alveolar proteinosis. The FDA granted Priority Review and set a PDUFA action date of August 22, 2026.

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