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Savara Submits FDA Application for Molbreevi to Treat Rare Lung Disease

Mar 15, 2026

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.

FDA Accepts Savara's MOLBREEVI Application for Autoimmune PAP with Priority Review

Feb 21, 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.