Replimune Group says FDA 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. on.wsj.com/4wJPDUl
on.wsj.comFDA Approves Replimune’s Melanoma Drug On Third AttemptThe agency had turned down two earlier applications over clinical data-quality concerns.
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