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How Low Can Gilenia Go? Panel Wants Reduced-Dose Phase IV Trial

Executive Summary

FDA should approve Novartis' Gilenia (fingolimod), an oral tablet intended to treat relapsing remitting multiple sclerosis, but should require the company to test a lower dose of the medication in a post-market clinical trial due to the product's many risks, a mostly united advisory panel said June 10

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Novartis' Risk Evaluation and Mitigation Strategy for Gilenia (fingolimod) may need to include more explicit testing requirements instead of just the physician and patient education programs that the firm has proposed

Gilenia's Risk Management Should Key On Initial Doctor Visit, Cmte. Says

Novartis' Risk Evaluation and Mitigation Strategy for Gilenia (fingolimod) may need to include more explicit testing requirements instead of just the physician and patient education programs that the firm has proposed

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