Replimune Secures FDA Approval for Melanoma Drug After Prolonged Regulatory Struggle

By Meghana Keshavan · STAT News · 2026-08-07

According to reporting from STAT News, Replimune has finally obtained accelerated approval for its melanoma therapy, RP1, following three rounds of agency review. The $450,000 treatment, marketed as Tudriqev, received the green light despite internal staff concerns regarding tria

According to reporting from STAT News, Replimune has finally obtained accelerated approval for its melanoma therapy, RP1, following three rounds of agency review. The $450,000 treatment, marketed as Tudriqev, received the green light despite internal staff concerns regarding tria