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Janssen Biotech Inc. submitted supplemental Biologics License Application for daratumumab (Darzalex) to FDA

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JANSSEN BIOTECH Inc. submitted a supplemental Biologics License Application for daratumumab (Darzalex) to FDA. The application seeks to expand the current indication, using daratumumab in combination with lenalidomide (an immunomodulatory agent) and dexamethasone, or bortezomib (a proteasome inhibitor [PI]) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one...

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