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FDA Approves Replimune's Tudriqev for Advanced Melanoma After Two Previous Rejections
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Fusion42 · 28 August 2026 · Fusion42 review
The FDA has granted accelerated approval to Replimune's Tudriqev, a virus-based immunotherapy combined with nivolumab, for adults with advanced unresectable melanoma who progressed on PD-1 blockade, reversing two prior rejections and addressing a patient group with limited options and poor prognosis.
This Wire brief sits within Fusion42's coverage of Biotech, and 14 sources have reported it between 6 Aug 2026 and 10 Aug 2026.
◆ ◆ The Wire takeaway
You have a new FDA-approved therapy option combining tumor injection with immunotherapy for advanced melanoma that previously required clinical trial access. Centres able to deliver image-guided tumor injections can now prescribe Tudriqev and must prepare for patient demand and safety monitoring.
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14 sources · first reported 6 Aug 2026 · latest 10 Aug 2026
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