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A look back at all the FDA news that happened in the month of May 2019, including several new approvals, orphan drug designations, breakthrough therapy designations, fast track designations, and more.

Combining lenalidomide with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone did not improve progression-free survival compared with placebo and R-CHOP as a frontline therapy in patients with activated B-cell-type diffuse large B-cell lymphoma, missing the primary endpoint of the phase III ROBUST trial.