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https://www.wsj.com/tech/biotech/fda-approves-replimunes-melanoma-drug-on-third-attempt-5018cccf
FDA Approves Replimune’s Melanoma Drug on Third Attempt
The agency had turned down two earlier applications over clinical data-quality concerns
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Replimune Group said Thursday that the Food and Drug Administration has approved its therapy for advanced skin cancer, ending a regulatory saga that spanned three submissions and two rejections and was a flashpoint in the tenure of the agency’s last commissioner.
Replimune’s drug, marketed as Tudriqev, is a genetically modified virus that doctors inject directly into tumors, where it is designed to kill cancer cells and trigger an immune response against tumors elsewhere in the body.
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