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Latest From Eiger BioPharmaceuticals, Inc.
Eiger's Lonafarnib Loses EU Fast-Track Review Status
Eiger attributes the change in status of the EU marketing authorization application for lonafarnib to the need for an inspection and the ongoing coronavirus pandemic.
Stacked User Fee Calendar Puts Another Record-Setting Year For US FDA Novel Approvals Within Reach
With goal dates for almost 40 novel drugs and biologics coming up in the second half of 2020 after a record number of first half approvals, even the pandemic looks unlikely to prevent another solid year for innovative drugs at US FDA.
EU Accelerated Assessment Tracker
At least another four investigational therapies will join the few that are already being fast-tracked at the European Medicines Agency.
EU Accelerated Assessment Tracker
Alnylam and Eiger join the select group of companies whose products have been granted fast-track status at the European Medicines Agency
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- Celladon Corporation