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- CBER official overturns Replimune melanoma drug rejection; AbbVie reports phase 3 success in multiple myelomaA CBER regulator has reversed a prior decision to reject Replimune's experimental melanoma therapy, allowing the program to move forward. AbbVie announced that its multiple myeloma candidate achie…
- Industry urges FDA to broaden prior-knowledge guidance for gene and cell therapiesIndustry groups have asked the U.S. Food and Drug Administration to broaden its draft guidance on the use of scientifically valid prior knowledge in developing gene therapies that involve genome ed…