Keeping Track: FDA Clears Motegrity And Second Herceptin Biosimilar, But Rebuffs SpecGx's Oxycodone
Executive Summary
The latest drug development news and highlights from our US FDA Performance Tracker.
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Intra-Cellular's Lumateperone Brings Mixed Results In Bipolar Depression
Firm will discuss Phase III data with the US FDA, calling results from a successful Phase III monotherapy study robust despite second Phase III study's failure. Lumateperone is under review for schizophrenia, with a 27 September action date.