Hansa Biopharma submitted an application for full marketing authorization to the European Medicines Agency.
Steady: 0 in the last 7 days
Updated oct 11
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How it started
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What happened
Hansa Biopharma submitted an application for full marketing authorization to 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.- Hansa Biopharma is seeking approval for its drug Idefirix in various markets, with SERB handling commercialization in EU member states.Sub-event
Hansa Biopharma applied for full marketing authorization with the EMA.1 source
Hansa Biopharma achieved conditional product approval based on Phase 3 trial results.1 source
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The entities involved
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Hansa Biopharma
company in Lund, Sweden
Nothing else this week.
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European Medicines Agency
highest regulatory authority on medicines in the European Union
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- PolyPid Ltd's product received FDA Priority Review and gained single authorization across EU states from the EMA.