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The European Medicines Agency (EMA) grants positive opinion for subcutaneous daratumumab in frontline and relapsed/refractory settings
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval for daratumumab (Darzalex®) subcutaneous (SC) formulation for the treatment of adult patients with myeloma in frontline and relapsed/refractory settings.