The accelerated clearance follows two earlier rejections and the support of an advisory panel that disputed the arguments of FDA scientists.
An article from
The accelerated clearance follows two earlier rejections and the support of an advisory panel that disputed the arguments of FDA scientists.
Published Aug. 6, 2026
The FDA approved Replimune's melanoma treatment Tudriqev on Aug. 6, 2026.
Mario Guti via Getty Images
Replimune wins accelerated FDA approval for RP1 in advanced melanoma after two rejections, despite data concerns. Drug combines…
The FDA approved Replimune’s treatment for advanced melanoma, dealing the company and patient advocates a big win after a…
The positive vote came despite persistent concerns from FDA scientists and positions the company to bounce back from two earlier…
In a remarkable turnaround, Replimune has reversed the fortune of its melanoma therapy, winning FDA approval after two prior…
The agency had twice rejected the engineered viral therapy over concerns about the design of Replimune's clinical trial
Replimune was among the drugmakers that had criticized the FDA for what they called inconsistent guidance around trials and…
