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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 Makary.

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biopharmadive.comStai leggendo3 mesi fa

Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks

Replimune files a third FDA application for RP1 (melanoma, 33% tumor response) after two rejections over 12 months. The ~80% stock surge signals a regulatory thaw at the FDA, whose unpredictability had been flagged as biotech's top investment headwind.

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venerdì 29 maggio 2026·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…
venerdì 29 maggio 2026·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.

Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks

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Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks

Timeline cronologica

Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks

Replimune to resubmit twice-rejected drug for approval after FDA shakeup

Replimune to resubmit twice-rejected drug for approval after FDA shakeup

Replimune to ask FDA for re-review of melanoma drug, as agency stands by past rejections

Replimune to resubmit melanoma drug RP1 after FDA shakeup

Pharmalittle: We're reading about Replimune drug getting third try at FDA approval, a Pfizer deal in China,…

Pharmalittle: We're reading about Replimune drug getting third try at FDA approval, a Pfizer deal in China, and more

Replimune to resubmit melanoma drug RP1 after FDA shakeup

Replimune to ask FDA for re-review of melanoma drug, as agency stands by past rejections