HGSI $26.51>FDA issues Discipline Review Letter expressing concerns regarding the risk benefit assessment of ZALBIN dosed every two weeks: Co announces that it has received preliminary written feedback through a Discipline Review Letter from the U.S. FDA regarding the co's Biologics License Application (BLA) seeking approval in the United States to market 900-mcg ZALBIN (albinterferon alfa-2b, known in Europe as JOULFERON) dosed every two weeks for the treatment of chronic hepatitis C. HGS and Novartis (NVS) -- a partner for Zablin -- are considering development of ZALBIN dosed every four weeks, and HGS previously reported the positive interim results of a Phase 2b study of this ZALBIN regimen.
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