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J&J preps case for quick FDA approval of new TB drug

from Fierce Biotech

Johnson & Johnson has set out to navigate its way through an important stage of its campaign to gain an accelerated approval for a new therapy for drug-resistant tuberculosis. A panel of outside FDA experts will give J&J's bedaquiline team a thorough examination to see whether the company warrants a preliminary approval based on Phase II data. And recently, the agency released its carefully neutral view of the data on safety and efficacy. more


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