Replimune tries again with melanoma drug post FDA shakeup

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Replimune is making another run at U.S. FDA approval for its melanoma candidate RP-1 after previous rejections. The company says it has reached alignment with the agency on resubmitting the BLA and expects the review to be prioritized. The update matters to readers tracking oncology, immuno-oncology, and FDA regulatory decisions in the life sciences sector. The article does not describe a software product, software company event, or ISV-specific business move.

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