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Keeping Track: Tpoxx Wins Green Light For Smallpox, Submissions Galore, And A Broader Approval For Xtandi

 
• By Michael Cipriano

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

Keeping Track Feature image

The biggest event this week in US review and approval news came at the end of it: Siga Technologies Inc.'s smallpox drug Tpoxx (tecovirimat) picked up the US FDA's blessing July 13, becoming the first product to land a Material Threat Medical Countermeasure priority review voucher under the 21st Century Cures Act, and also the first agency-backed smallpox drug.

But Topxx wasn't the only product to have a first. Highlighting a busy week of filings, Enzyvant Sciences Ltd.'s complete DiGeorge Anomaly (cDGA) candidate RVT-802 became the first with...

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