FDA approves Replimune melanoma drug previously rejected twice

FDA approves Replimune's melanoma drug after two prior rejections

The FDA granted accelerated approval to Replimune's TUDRIQEVTM (vusolimogene oderparepvec-wtpg) for melanoma treatment, reversing two earlier rejections following support from an advisory panel. The approval marks a significant turnaround for the biotech company after a tumultuous regulatory process.