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Jul 23, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Simponi golimumab regulatory update

Johnson & Johnson submitted an sBLA to FDA and a Type II variation to EMA seeking to expand the label of subcutaneous Simponi golimumab to include treatment of moderately to severely active ulcerative colitis in adults who had an inadequate response to conventional therapy. J&J markets a subcutaneous formulation of Simponi in 52 countries for rheumatologic...

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