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U.S. FDA approves ImmunityBio's bladder cancer therapy The U.S. health regulator on Monday approved ImmunityBio's (IBRX.O), opens new tab combination therapy to treat a type of bladder cancer, marking an end to the company's efforts to bring its therapy to the market. The agency's green light is a shot in the arm for ImmunityBio, which had reiterated doubts in a regulatory filing, opens new tab last month about its ability to remain in business. Last year, the U.S. Food and Drug Administration declined clearance for the therapy, Anktiva, over deficiencies found during pre-license inspection of the company's contract manufacturing firms. The therapy works by activating types of disease fighting white blood cells called natural killer (NK) cells and T-cells to create long-term immunity in the body. The company did not immediately respond to a request seeking details on the therapy's label, availability and pricing. ImmunityBio's drug is used in combination with the Bacillus Calmette-Guérin (BCG) vaccine, which is mainly used against tuberculosis, but also as a common treatment for some forms of bladder cancer. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-immunitybios-bladder-cancer-therapy-2024-04-22/