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Janssen Submits Application to the FDA Seeking Approval of New Darzalex Subcutaneous Formulation for Treatment of Multiple Myeloma

11:51 EDT 15 Jul 2019 | Speciality Pharma Journal

RARITAN, N.J., July 12, 2019  — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new subcutaneous (SC) formulation of DARZALEX® (daratumumab), an intravenous (IV) treatment approved for certain patients with multiple myeloma. The submission …

Original Article: Janssen Submits Application to the FDA Seeking Approval of New Darzalex Subcutaneous Formulation for Treatment of Multiple Myeloma

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