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Replimune to ask FDA for re-review of melanoma drug, as agency stands by past rejections
Replimune will resubmit advanced melanoma drug RP1 to the FDA after two rejections, following the ouster of Commissioner Marty Makary; shares jumped about 70%.
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biopharmadive.com
Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks
A twice-spurned therapy that’s been seen as one of the FDA’s more controversial recent rejections is getting a new chance following the resignation of former commissioner Marty…
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cnbc.com
Replimune to resubmit twice-rejected drug for approval after FDA shakeup
Replimune was among the drugmakers that had criticized the FDA for what they called inconsistent guidance around trials and approvals.
