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The fda evaluated libtayo under priority review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in the treatment of serious conditions In a significant step forward for skin cancer management, the u.s An additional regulatory application is also under review in the european union, with a decision expected by the first half of 2026.

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Cemiplimab is the first immunotherapy approved for adjuvant treatment in cscc, offering a new option for patients at high risk of recurrence. Findings showed cemiplimab reduced the risk of disease recurrence or death by 68% compared with placebo See important safety & full prescribing information.