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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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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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Timeline cronologica

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

Confronto fonti

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

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

Replimune to resubmit melanoma drug RP1 after FDA shakeup

Why Is Replimune Stock Gaining Monday? - Replimune Group (NASDAQ:REPL)

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

Why Is Replimune Stock Gaining Monday? - Replimune Group (NASDAQ:REPL)