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This was Citius second try for FDA approval, after the regulator rejected Lymphir in July 2023, outlining the need for enhanced product resting requirements. In its resubmitted data package, the company included findings from the from the Phase III Study 302 trial, where treatment with the drug led to an objective response rate of 36.2%, with 8.7% reaching complete response

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The Master Complaint claims failure to provide sufficient warnings about the increased risk, breach of warranties, fraudulent concealment, unfair trade practices, strict product liability, misrepresentation, negligent design and on and on and on