Keeping Track: Zelboraf Takes Breakthrough Path For Rare Blood Disease; Teva Resubmits Generic EpiPen
The latest drug development news and highlights from our US FDA Performance Tracker.
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After meeting with FDA to discuss the status of its Advair generic application in the US, Mylan said it will not have to conduct additional clinical trials and is on target to respond to the complete response letter soon.
UK-based Mallinckrodt's purchase of InfaCare gives it a late-stage asset for severe jaundice in infants while leaving room for further M&A.
Center for Drug Evaluation and Research Director Janet Woodcock continues to promote innovation in clinical trial design with a review of master protocols in the New England Journal of Medicine.