CHICAGO–(BUSINESS WIRE)–Celltrion USA today announced the submission of a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a “stand-alone” BLA) for lead product candidate, CT-P13 SC, which is the subcutaneous formulation of infliximab to the U.S. Food and Drug Administration (FDA). The planned initial submission package will seek […]

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