EU Accelerated Assessment Tracker

Two products that were under fast-track review at the European Medicines Agency have reverted to standard review timelines – Eiger's lonafarnib and GSK's dostarlimab. The Pink Sheet tracker logs these and other developments relating to the agency's accelerated assessment mechanism.

The tracker below provides information on accelerated assessment requests for planned marketing authorization applications (MAAs) that have come before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

This latest update reflects the fact that two MAAs that were being reviewed under the accelerated assessment mechanism have reverted to standard review timelines. The MAAs relate to GlaxoSmithKline's dostarlimab...

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