ImmunityBio Inc said on Thursday the U.S. Food and Drug Administration has declined to approve its combination therapy to treat a type of bladder cancer due to deficiencies in the company's application.
said on Thursday the U.S. Food and Drug Administration has declined to approve its combination therapy to treat a type of bladder cancer due to deficiencies in the company's application.ImmunityBio, in a filing with the Securities and Exchange Commission, also reiterated doubts about its ability to remain in business.
In a letter to the company on Tuesday, the health regulator flagged deficiencies related to the FDA's pre-license inspection of the company's third-party contract manufacturing firms. The health regulator did not request any new preclinical or late-stage clinical trials to evaluate the safety or efficacy of the therapy, but requested the company to provide more data and a safety update in its resubmission.
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