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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.

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cnbc.comStai leggendo22 h fa

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.

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endpoints.news20 h fa

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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qz.com21 h fa

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.com1 g 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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Replimune to resubmit twice-rejected drug for approval after FDA shakeup

Confronto fonti

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

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 melanoma drug RP1 after FDA shakeup

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

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

Confronto fonti

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

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 melanoma drug RP1 after FDA shakeup

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