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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…
- FDA advisory panels for Capricor and Replimune highlight need for rare-disease specialist inputRecent FDA advisory committee meetings reviewing therapies from Capricor Therapeutics and Replimune produced markedly different outcomes, underscoring how the agency’s reliance on specialist input…