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Approval for Astrazeneca, Merck & Co.; designation for Savara

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Approval for Astrazeneca, Merck & Co.; designation for Savara

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Jan. 3.


* 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.

SNL ImageFDA headquarters in Silver Spring, Md.
Source: AP Photo

Breakthrough therapy

* Savara Inc.'s Molgradex for autoimmune pulmonary alveolar proteinosis.