Iressa User Fee Date Pushed To May; Will Advisory Cmte. Take Second Look?
Executive Summary
FDA will take regulatory action on AstraZeneca's Iressa (gefitinib) by May 5
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Iressa Clears FDA: Phase IV Symptom Trial Will Be First Shot At Full Approval
AstraZeneca's first chance to secure traditional approval for Iressa will be a randomized trial assessing symptom improvement in non-small cell lung cancer due to be submitted to the agency by June 2005
Iressa Clears FDA: Phase IV Symptom Trial Will Be First Shot At Full Approval
AstraZeneca's first chance to secure traditional approval for Iressa will be a randomized trial assessing symptom improvement in non-small cell lung cancer due to be submitted to the agency by June 2005
Iressa Postmarketing Trial Modeled On Tarceva Phase III Under Consideration
FDA is understood to be considering the design of OSI/Genentech/Roche's Tarceva Phase III trial in refractory non-small cell lung cancer as a model for a postmarketing trial for AstraZeneca's Iressa