Good news strikes from an unlikely source. On Thursday the Food and Drug Administration approved Replimune’s immunotherapy for metastatic melanoma, a day after it green-lighted mFlusiva, Moderna’s mRNA flu vaccine. The shame is that both might have been available sooner but for regulatory delays, which hurt both patients and American innovation.
Replimune has been working on its RP1 immunotherapy for a decade but got caught in the FDA cross-hairs at the last stretch. FDA review staff recommended approval after its late-stage trial showed that a third of patients whose…
