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Jul 09, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Bedaquiline regulatory update

Johnson & Johnson's Janssen Research & Development LLC subsidiary submitted an NDA to FDA for bedaquiline to treat multi-drug resistant tuberculosis (MDR-TB). Janssen is seeking accelerated approval for bedaquiline based on data from the Phase II TMC207-C208 and TMC207-C209 trials in 394 patients. Janssen plans to start...

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