FDA Clears Replimune Melanoma Drug as Medicare Tweaks Pricing Timeline

By Ed Silverman · STAT News · 2026-08-07

FDA Clears Replimune Melanoma Drug as Medicare Tweaks Pricing Timeline

STAT News reports that the FDA granted accelerated approval to Replimune’s melanoma treatment, Tudriqev, despite previous trial design concerns raised by agency staff. Separately, a quiet adjustment to Medicare’s drug negotiation criteria has delayed price discussions for a high-

STAT News reports that the FDA granted accelerated approval to Replimune’s melanoma treatment, Tudriqev, despite previous trial design concerns raised by agency staff. Separately, a quiet adjustment to Medicare’s drug negotiation criteria has delayed price discussions for a high-