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Amgen shares new analysis with FDA in bid to keep Tavneos on the market
Amgen submitted new analyses to FDA supporting Tavneos staying on market, disputing data manipulation claims.
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fiercepharma.com
Amgen hands in data package in hopes of FDA hearing for Tavneos defense
With all eyes on Tavneos’ seemingly precarious approval status in the U.S., Amgen is advancing plans to defend the ANCA-associated vasculitis (AAV) drug it inherited in its $3.7…
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medpagetoday.com
FDA Gets New Avacopan Analysis After Alleging Data Manipulation
Agency has been calling for the vasculitis drug to be pulled from the market since January
