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US FDA approves Replimune's skin cancer drug
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Fusion42 · 7 August 2026 · Fusion42 review
The US FDA approved Replimune's drug Tudriqev for advanced melanoma after multiple rejections, marking the company's first marketed product. The therapy involves a genetically modified herpes virus injected into tumors to kill cancer cells and stimulate immune response, priced at $450,000 per course and expected to ship in 60 days.
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 must ready your market and regulatory strategy for new skin cancer immunotherapies; Tudriqev's FDA nod after prior refusals opens a new pathway for competing products and patient access. Prepare for commercial and clinical trials shifts as this treatment nears launch and market share expansion.
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14 sources · first reported 6 Aug 2026 · latest 10 Aug 2026
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