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FDA, Tudriqev and Replimune

· 7h · on MSN

Replimune wins FDA skin cancer drug approval on third try. Why the stock is tumbling.

Replimune secures FDA approval for Tudriqev on its third attempt, making it the company’s first product on the market.

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FDA approves Replimune's Tudriqev melanoma drug on third try

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 ...

1d

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, ...

8d

Replimune: 'Sell' Continued Doubt On Single-Arm IGNYTE Trial For RP1 FDA Review

Replimune had its Type A FDA meeting to see if it could still have a path forward for its RP1 + OPDIVO combination. See why ...

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