This report was first published by Endpoints News. To see the original version, click here
The FDA has once again rejected Replimune’s oncolytic virus therapy to treat advanced melanoma.
The Massachusetts-based drugmaker had been pushing for a reconsideration by the agency since the therapy was first rejected last July. At the time, it argued that the FDA’s complete response letter came out of left field after what it thought were productive discussions with the agency.
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