FDA advisory panel recommends approval of TB Alliance’s tuberculosis treatment
Independent experts of an FDA advisory panel voted in favor of the not-for-profit TB Alliance’s treatment for drug resistant tuberculosis, as a part of a three-drug combination regimen.
The panel on Tuesday voted 14-4 when asked to assess the treatment, pretomanid, in combination with Johnson & Johnson’s bedaquiline and linezolid for multi-drug resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB).
Although the U.S. health regulator is not bound to follow the advice of its advisory panels, it usually does so.
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