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TB Alliance's Pretomanid Seems OK Heading To Advisory Cmte. As US FDA Showcases Regulatory Flexibility

 
• By Michael Cipriano

The Global Alliance for TB Drug Development is seeking an approval for pretomanid as part of an oral combination regimen for highly resistant tuberculosis. 

Tuberculosis
TB Alliance's Pretomanid Heads To A US FDA Advisory Committee In Good Shape

The not-for-profit Global Alliance for TB Drug Development will bring its tuberculosis candidate pretomanid before the Antimicrobial Drugs Advisory Committee on 6 June seemingly without any major concerns from US Food and Drug Administration reviewers, who look to be exhibiting a degree of regulatory flexibility.

TB Alliance is developing pretomanid, a nitroimidazooxazine antimycobacterial drug, specifically as part of an oral combination regimen with Janssen Pharmaceutical Cos.'s Sirturo (bedaquiline) and Pfizer Inc

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