5:08 PM
 | 
Nov 26, 2012
 |  BC Extra  |  Company News

FDA releases bedaquiline briefing docs

FDA's Anti-Infective Drugs Advisory Committee will discuss on Wednesday whether safety and efficacy data support accelerated approval of Sirturo bedaquiline from Johnson & Johnson (NYSE:JNJ) to treat multi-drug-resistant tuberculosis (TB). In briefing documents released ahead of the meeting, agency reviewers said 400 mg daily bedaquiline significantly reduced the time to sputum culture...

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