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Global Alliance for TB Drug Development

www.tballiance.org

Latest From Global Alliance for TB Drug Development

US FDA's Antimicrobial Head Ed Cox Leaves For Regeneron; Agency Needs New LPAD Champion

Long-time deputy John Farley becomes acting director of the Office of Antimicrobial Products. Cox, who served as the director of the office for more than a decade, joins Regeneron to serve as vice president of regulatory affairs.

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Keeping Track: A Quintet Of Novel Approvals

The latest drug development news and highlights from our US FDA Performance Tracker. 

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Pink Sheet Podcast: Zolgensma Saga Continues, ICER Reviews DMD Drugs, FDA Issues Another LPAD Approval

Pink Sheet reporters review Novartis' latest response to Zolgensma data manipulation, discuss ICER reviews of Sarepta's Duchenne muscular dystrophy treatments, and recap the FDA's latest antibiotic approval.

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Pretomanid Approval For Resistant TB: With Regulatory Flexibility Comes Usage Restrictions

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.

Approvals Review Pathway
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