Ukoniq Launch Starts TG Therapeutics' Commercial Path
A first-in-class PI3K/CK1 epsilon inhibitor, Ukoniq was approved by the US FDA for two types of lymphoma.
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The agency has suspended enrollment in Ukoniq trials while also hinting at greater scrutiny of “the continued marketing” of the drug.
PI3K-delta inhibitors have often suffered from safety and tolerability issues, but Phase II data show higher efficacy and lower discontinuation rates for zandelisib than others in the class.
Emerging biopharma companies developed and launched 40% of all new drugs that hit the market in the US in 2020, a significant increase from five years ago, according to IQVIA.