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  • CNBC5/29/2026, 12:51:06 PM
    Replimune to resubmit twice-rejected drug for approval after FDA shakeup

    Replimune plans to resubmit a drug that has been rejected twice by the FDA, following recent organizational changes at the agency. The company had previously criticized the FDA for what it described as inconsistent guidance around clinical trials and approvals. The resubmission signals renewed confidence that the regulatory environment may be more favorable under the restructured FDA.

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