TG Therapeutics scores priority review for PI3Kδ inhibitor; Galapagos searches for IBD targets in new pact
TG Therapeutics’ pitch for umbralisib as a safer PI3Kδ inhibitor has convinced the FDA to put it on the fast lane.
Regulators have accepted the NDA for the once-daily drug, a dual inhibitor of PI3K-delta and CK1-epsilon first aimed at two indications: marginal zone lymphoma patients who have received at least one anti-CD20-based regimen, and follicular lymphoma patients who have gone through at least two lines of systemic therapies.
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