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US FDA approves Replimune's skin cancer drug after prior rejections
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Fusion42 · 30 August 2026 · Fusion42 review
The US FDA approved Replimune's genetically modified herpes virus drug Tudriqev for advanced melanoma after prior rejections; the drug will be marketed in combination with Bristol Myers Squibb's Opdivo and is expected to ship within 60 days at a price of $450,000.
This Wire brief sits within Fusion42's coverage of Biotech, and 4 sources have reported it between 7 Aug 2026 and 10 Aug 2026.
◆ ◆ The Wire takeaway
You now face a commercial market with a high-cost alternative to surgical melanoma treatments. If you build therapies or services around PD-1 relapsed melanoma, this regulatory approval changes the competitive stakes immediately.
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4 sources · first reported 7 Aug 2026 · latest 10 Aug 2026
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