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Replimune melanoma drug snags coveted FDA approval after yearlong clash, two rejections
Replimune wins accelerated FDA approval for RP1 in advanced melanoma after two rejections, despite data concerns. Drug combines oncolytic virus with Opdivo.
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6 prospettive sulla stessa storiaTimeline cronologica
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biopharmadive.com
Replimune rebounds to win FDA approval of melanoma drug
The accelerated clearance follows two earlier rejections and the support of an advisory panel that disputed the arguments of FDA scientists.
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medpagetoday.com
FDA Finally OKs Twice-Rejected Melanoma Drug
Approved in combination with nivolumab for patients who progress on prior anti-PD-1 therapy
