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FDA, Replimune and Tudriqev

FDA approves Replimune's Tudriqev melanoma drug on third try

The agency had twice rejected the engineered viral therapy over concerns about the design of Replimune's clinical trial

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Replimune Wins FDA Skin Cancer Drug Approval on Third Try. Why the Stock Is Tumbling.

Fierce Pharma · 1d

UPDATED: Replimune secures FDA approval for melanoma therapy Tudriqev after long regulatory battle

FDA says Replimune’s melanoma data package is ‘not interpretable,’ setting up tough adcomm

The FDA's rebuff of Replimune comes a day after the agency similarly called into question the Phase 3 trial for Capricor’s ...

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Replimune Announces FDA Accelerated Approval of TUDRIQEVTM in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based ...

Broad label to address high unmet need in advanced melanomaReplimune will host conference call on August 6, 2026 at 4:30 p.m. ET. WOBURN, ...

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