Replimune said the FDA has accepted the resubmission of its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma. The acceptance keeps the regulatory review process moving forward and reduces near-term uncertainty around the program. The update is positive for the company, though it is a procedural milestone rather than an approval decision.
Replimune said the FDA has accepted the resubmission of its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma. The acceptance keeps the regulatory review process moving forward and reduces near-term uncertainty around the program. The update is positive for the company, though it is a procedural milestone rather than an approval decision.
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