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TG Therapeutics Pulls Ukoniq/Ublitiximab Combo Applications Due To Adverse Survival Trend

Executive Summary

Company also withdraws Ukoniq, a P13K inhibitor, just 14 months after accelerated approval in two lymphoma indications. US oncology drugs panel will discuss safety concerns with the PI3K class on 21 April, but FDA has already staked out its position in a Lancet commentary that a new development approach is needed with survival as the ultimate safety endpoint.

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