FDA clears RP1 melanoma therapy after regulatory rollercoaster
TL;DR
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.
- FDA approves Replimune melanoma drug previously rejected twice STAT
- FDA Approves Replimune’s Melanoma Drug on Third Attempt wsj.com
- Replimune secures FDA approval for melanoma therapy Tudriqev after long regulatory battle Fierce Pharma
- US FDA approves Replimune's skin cancer drug after prior rejections Reuters
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