U.S. FDA Accepts Seattle Genetics' (SGEN) Brentuximab Vedotin BLA
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Seattle Genetics, Inc. (Nasdaq: SGEN) reports that the U.S. Food and Drug Administration (FDA) has accepted for filing two Biologics License Applications (BLAs) for brentuximab vedotin.
The FDA administratively separated the original BLA submission and will act individually on the application for each indication.
In addition, the FDA has granted a six-month priority review of both applications, and has established an action date of August 30, 2011 under the Prescription Drug User Fee Act (PDUFA).
The FDA administratively separated the original BLA submission and will act individually on the application for each indication.
In addition, the FDA has granted a six-month priority review of both applications, and has established an action date of August 30, 2011 under the Prescription Drug User Fee Act (PDUFA).
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