Keeping Track: Sarepta User Fee Extended; CTI/Baxalta Pull Pacritinib NDA
The latest drug development news and highlights from our FDA Performance Tracker.
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FDA wants another clinical trial for Duchenne muscular dystrophy treatment; focus moves to Sarepta's candidate, which gets committee review next week.
Round-up of late summer applications recently submitted to US FDA, adapted from the Pink Sheet FDA Performance Tracker's User Fee Goal Dates chart.
Recent submissions include what could be the fourth novel agent approved under the RTOR pilot.