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To view or add a comment, sign in FDA Approval Update The FDA has approved Sarclisa Escena (isatuximab-irfc) from Sanofi as a subcutaneous formulation of isatuximab for approved multiple myeloma treatment combinations

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Overarching Principle The fundamental principle of regulation of medicines is to optimise timely access to effective treatments while reducing the risk of harm from improper use

Its a conservative, reasonable default

Human controlled trial data is still absent, so confidence is low

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