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- Industry urges FDA to broaden prior-knowledge guidance for gene and cell therapiesIndustry stakeholders have asked the U.S. Food and Drug Administration to expand the scope of its recent draft guidance on scientifically valid prior knowledge for gene therapies that involve genom…
- 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…