- Omeros Corporation, based in Seattle, has submitted a Biologics License Application (BLA) to the FDA seeking approval for its drug candidate, narsoplimab.
- Omeros Corporation's drug received FDA approval and is currently undergoing review by the European Medicines Agency.
The FDA and European Medicines Agency engaged in joint coordination regarding regulatory dossier evaluation.
1 report, 1 independent
Updated Jun 30
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What happened
The FDA and European Medicines Agency engaged in joint coordination regarding regulatory dossier evaluation.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.- Hospitals in India, Israel, and the Netherlands are currently experimenting with dose reduction protocols for clinical trials under the purview of the FDA and the European Medicines Agency.Sub-event
FDA and EMA coordinated on regulatory dossier evaluation.1 source
Keep exploring
The entities involved
- FDA
-
European Medicines Agency
highest regulatory authority on medicines in the European Union
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