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FDA approves Replimune's Tudriqev melanoma drug on third try
The agency had twice rejected the engineered viral therapy over concerns about the design of Replimune's clinical trial
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biopharmadive.com
Replimune rebounds to win FDA approval of melanoma drug
The accelerated clearance follows two earlier rejections and the support of an advisory panel that disputed the arguments of FDA scientists.
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statnews.com
FDA approves Replimune melanoma drug previously rejected twice
The FDA approved Replimune’s treatment for advanced melanoma, dealing the company and patient advocates a big win after a tumultuous saga.
