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Replimune to resubmit melanoma drug RP1 after FDA shakeup
The FDA rejected vusolimogene oderparepvec twice under former Commissioner Marty Makary, who stepped down earlier this month
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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.
