FDA clears RP1 melanoma therapy after regulatory rollercoaster
TL;DR Summary
The FDA granted accelerated approval for Replimune's RP1 (brand Tudriqev) for advanced melanoma after an advisory panel backed efficacy signals despite concerns about trial design, ending a regulatory saga that included two prior rejections; the therapy is priced at $450,000 per course.
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- US FDA approves Replimune's skin cancer drug after prior rejections Reuters
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