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Roche and fda agree on pathway towards u.s. approval of actemra (tocilizumab)
Roche, 12/05/08
Roche announced that the U.S. Food and Drug Administration (FDA) has provided further guidance on the requirements for the Biologics License Application (BLA) for ACTEMRA (tocilizumab), the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).
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