Omeros Corporation's drug received FDA approval and is currently undergoing review by the European Medicines Agency.
2 reports, 1 independent
Updated Oct 16
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- Developments
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New informationRepeats or wire copies
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What happened
Omeros Corporation's drug received FDA approval and is currently undergoing review by the European Medicines Agency.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.EMA issued a negative opinion on Omeros's drug application.1 source
- The FDA and European Medicines Agency engaged in joint coordination regarding regulatory dossier evaluation.Sub-event
Omeros's drug received FDA approval and is now under EMA review.1 source
Keep exploring
The entities involved
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Omeros Corporation
company in Seattle, United States
Nothing else this week.
- FDA
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European Medicines Agency
highest regulatory authority on medicines in the European Union
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