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The FDA has approved Auxilium Pharmaceuticals’ Xiaflex biologic injection for Peyronie’s disease, a deformity of the penis caused by a lump of plaque that results in a curvature of at least 30 degrees.
The FDA has approved a new indication for Roche’s Actemra to treat adults with moderately to severely active rheumatoid arthritis (RA) who have responded poorly to one or more disease-modifying anti-rheumatic drugs. The regulatory nod makes Actemra (tocilizumab) the first humanized IL-6 receptor-inhibiting monoclonal antibody approved for such an indication, Roche’s Genentech unit said. Drug Industry Daily