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In a remarkable turnaround, Replimune has reversed the fortune of its melanoma therapy, winning FDA approval after two prior rejections and agency leadership shakeups. | In a remarkable turnaround, Replimune has reversed the fortune of its melanoma therapy, winning FDA approval after two prior rejections and agency leadership shakeups.
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Replimune rebounds to win FDA approval of melanoma drug

FDA approves Replimune melanoma drug previously rejected twice

Replimune melanoma drug snags coveted FDA approval after yearlong clash, two rejections

FDA approves Replimune's Tudriqev melanoma drug on third try

FDA OKs accelerated approval to twice-rejected Tudriqev with Opdivo for advanced melanoma

The accelerated clearance follows two earlier rejections and the support of an advisory panel that disputed the arguments of FDA…

The FDA approved Replimune’s treatment for advanced melanoma, dealing the company and patient advocates a big win after a…

Replimune wins accelerated FDA approval for RP1 in advanced melanoma after two rejections, despite data concerns. Drug combines…

The agency had twice rejected the engineered viral therapy over concerns about the design of Replimune's clinical trial

A twice-spurned therapy that’s been seen as one of the FDA’s more controversial recent rejections is getting a new chance…

The positive vote came despite persistent concerns from FDA scientists and positions the company to bounce back from two earlier…