Keeping Track: New Drugs For IBS, LAM; New NDAs for HCV and Hyperkalemia
Executive Summary
The latest drug development news and highlights from our FDA Performance Tracker.
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Actavis And Valeant Now Squaring Off For IBS Patients
Viberzi and Xifaxan share an indication and an approval date, but not much else.
PTC’s Upstaza Takes Gene Therapy Straight To Brain (And US FDA); Translarna To Return Mid-Year
In a year full of regulatory milestones for the firm, PTC Therapeutics hopes to set some approval precedents – and basically hopes its candidates have an easier time of it than they have had before.
BeiGene’s Tevimbra And The End Of The COVID Inspection Era
US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.