Close

U.S. FDA Accepts Seattle Genetics' (SGEN) Brentuximab Vedotin BLA

May 2, 2011 6:50 AM EDT
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).


Serious News for Serious Traders! Try StreetInsider.com Premium Free!

You May Also Be Interested In





Related Categories

Corporate News, FDA