Keeping Track: FDA Approves First Generic Advair, But Alkermes And Sunovion Land CRLs
Executive SummaryThe latest drug development news and highlights from our US FDA Performance Tracker.
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Keeping Track Of Thanksgiving Leftovers: Risdiplam, Artesunate Highlight Glut Of Submissions/Filings
Yes, we know they should be out of the fridge by now, but here are the highlights of submissions and filings during the Thanksgiving week.
The latest submission and expedited review program news and highlights from our US FDA Performance Tracker.
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.