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Approval for Astrazeneca, Merck & Co.; designation for Savara
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The Market Intelligence Platform
Approvals and designations made by the U.S. Food and Drug Administration for the week ended Jan. 3.
Approvals
* AstraZeneca PLC and Merck & Co. Inc.'s Lynparza as a stand-alone maintenance therapy for BRCA-mutated pancreatic cancer that has spread but has not progressed for at least 16 weeks following first-line platinum-based chemotherapy.
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Breakthrough therapy
* Savara Inc.'s Molgradex for autoimmune pulmonary alveolar proteinosis.
FDA headquarters in Silver Spring, Md.