Home » FDA Wants Safety Update Before Approving Cimzia
FDA Wants Safety Update Before Approving Cimzia
Belgian drugmaker UCB has received a complete response letter to its BLA filing for Cimzia to treat rheumatoid arthritis. The FDA has requested a new safety update that includes clinical data generated since the BLA was accepted for filing and review last February. A UCB spokesman said the company plans to have a Type A meeting with the agency to discuss the next steps.
Washington Drug Letter
Washington Drug Letter
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