GSK Will Answer FDA “Complete Response” Letter For Cervarix In Q2
Executive Summary
GlaxoSmithKline will answer FDA's "complete response" letter for its Cervarix BLA in the second quarter, but the firm expects the product will require advisory committee review for final approval, CEO JP Garnier said during GSK's year-end earnings call
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FDA has unveiled the much-anticipated labeling change for GlaxoSmithKline's type 2 diabetes therapy Avandia, but is deeming the information about rosiglitzone's cardiovascular risk "inconclusive" and is asking the sponsor to undertake a long-term outcomes study to address outstanding safety questions