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FDA sets approval path for Prosensa muscle disorder drug
Reuters: Prosensa Holding NV said the U.S. Food and Drug Administration had outlined an accelerated regulatory approval path for its most advanced drug, aimed at treating a muscle disorder.
The Netherlands-based company said on Tuesday it planned to conduct two more studies, and file for U.S. marketing approval later this year. Prosensa said it would file for European approval in the near future.
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