Roche and FDA Agree on Pathway Towards U.S. Approval of Actemra (tocilizumab)
...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...
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FDA Advisory Committee Recommends Approval of Actemra (tocilizumab) for the Treatment of Rheumatoid Arthritis
...that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) by a near unanimous (10-1) vote recommended approval of Actemra (tocilizumab), a novel interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody, for reducing the signs and symptoms in adults with moderate...
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Roche Submits Application for FDA Approval of Actemra for the Treatment of Rheumatoid Arthritis
...announced today the submission of a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval to market Actemra (tocilizumab) to reduce the signs and symptoms in adults with moderate to severe rheumatoid arthritis (RA). 'The filing for Actemra represents...
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FDA Issues Complete Response Letter to Roche for Acterma (tocilizumab) Biologics License Application
...announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter 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...
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