Slew Of New Drugs Accepted For EU Market Review, Three For Fast Track
Four orphan drugs, Roche’s tissue agnostic cancer treatment entrectinib, and a single-dose oral vaccine for cholera are among the raft of new products that the European Medicines Agency has started to review for potential approval across the EU.
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New medicines under evaluation at the European Medicines Agency.
The latest drug development news and highlights from our US FDA Performance Tracker.
The European Medicines Agency will fast-track Shionogi’s new antibiotic, , through regulatory review when the company files for approval but there’s no special treatment for Roche’s new tissue agnostic oncologic, . More than half the accelerated assessment requests made in 2018 to the EMA failed to make the grade.