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Keeping Track: US FDA Approvals For Tibsovo, Kisqali And Second Neupogen Biosimilar

 
• By Michael Cipriano and Bridget Silverman

The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track Feature image

The news in brief this week is that novel drug approvals continue to pour out of the US FDA, with Agios Pharmaceuticals Inc.'s acute myeloid leukemia (AML) therapy Tibsovo (ivosidenib) becoming No. 22 in 2018.

But a non-novel product also grabbed the spotlight, with Novartis AG’s breast cancer therapy Kisqali (ribociclib) becoming the first drug approved under FDA’s pilot Real-Time Oncology Review program

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