FDA approves Replimune melanoma drug previously rejected twice

Reversal, capping a tumultuous saga, is a big win for the biotech company, patient advocates

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By Elaine ChenAug. 6, 2026

Chen, a national biotech reporter, is the co-author of The Readout, a newsletter about the business, science, and politics of biotech.

Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.

FDA approves Replimune melanoma drug previously rejected twice

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