Savara submits BLA for MOLBREEVI with FDA priority review set for August
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Savara Reports Fourth Quarter and Year End 2025 Financial Results and Provides Business Update
March 13, 2026 8:05 AM EDTAchieved Regulatory Milestones for the MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Development Program: U.S. Food and Drug Administration (FDA) filed the Biologics License Application (BLA) Priority Review granted, Prescription Drug User Fee Act (PDUFA) date set for August 22, 2026 FDA indicated an Advisory Committee is not planned for the BLA Submitted Marketing Authorization Applications (MAAs) to the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare Products Regulatory Agency... More
