Albireo Pharma, Inc.
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Latest From Albireo Pharma, Inc.
October and November 2020 were bad months for companies seeking to have their planned EU filings fast-tracked through the centralized drug review system at the European Medicines Agency.
Bayer has failed to convince the European Medicines Agency that its marketing authorization application for finerenone should be fast-tracked through the EU's centralized review process. There were other successes, though, although Janssen is keeping us guessing over its MAA for amivantamab. These and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.
A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.
Among the 13 new drug marketing applications that the European Medicines Agency has most recently accepted for review are two products that could become the first approved treatments for children with progressive familial intrahepatic cholestasis, a life-threatening disorder.
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