The U.S. Food and Drug Administration is investigating a possible death risk for TG Therapeutics’ Ukoniq (umbralisib), which is indicated for two types of lymphoma.
Significant advancements in the treatment of relapsed or refractory large B-cell lymphoma are on the horizon. At the American Society of Hematology meeting, both Bristol Myers Squibb and Kite Pharma presented promising data from CAR-T programs aimed at this disease.
Bristol Myers Squibb is withdrawing the biopharmaceutical giant’s Istodax from the market after recent trials showed that the peripheral T-cell lymphoma drug did not achieve primary efficacy endpoint.
MorphoSys is acquiring Constellation Pharmaceuticals for about $1.7 billion and announced a partnership with Royalty Pharma for $1.425 billion up front.
Less than a month after submitting an Investigational New Drug (IND) application, Anixa Biosciences ran into a snag with the U.S. Food and Drug Administration as the government agency asked for more information before approving a clinical study on the company’s Chimeric Antigen Receptor-T cell therapy (CAR-T).
Regeneron Pharmaceuticals Inc. paused patient enrollment in two clinical studies testing the company’s experimental lymphoma drug, after the U.S. health regulator requested changes in trial protocols.
The U.S. Food and Drug Administration granted earlier-than-expected approval to Roche Holding AG’s antibody-drug conjugate Polivy for the treatment of patients with advanced lymphoma.
