TB Alliance's Pretomanid Seems OK Heading To Advisory Cmte. As US FDA Showcases Regulatory Flexibility
The Global Alliance for TB Drug Development is seeking an approval for pretomanid as part of an oral combination regimen for highly resistant tuberculosis.
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US FDA's approval of the TB Alliance's pretomanid regimen for highly treatment-resistant tuberculosis comes with an LPAD designation and advisory committee-requested language to limit use.
In an exclusive interview with Generics Bulletin sister publication the Pink Sheet, the now-permanent OTBB director Sarah Yim discussed her expectations for the future of the US biosimilars market, her learning experience as acting director and upcoming challenges for her office.