U.S. Phase 3 Study 15302 involving Kolon TissueGene failed, with the FDA being aware of the situation.
1 report, 1 independent
Updated Jul 1
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What happened
U.S. Phase 3 Study 15302 involving Kolon TissueGene failed, with the FDA being aware of the situation.
Who's involved
What this event is mainly aboutKeep exploring
The entities involved
- FDA
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Kolon TissueGene
Nothing else this week.
Related events
- FDA placed a clinical hold on Phase 2/3 trials for SK Biopharm on September 1, 2026.
- The FDA granted Safe to Proceed for the Pivotal Phase 3 study of Vivace Therapeutics, Inc.
- A study protocol involving a company based in Mont-Saint-Guibert was approved by the U.S. FDA.
- FDA classified a device failure involving ERBE as Class 2 on August 27, 2026.
Coverage
Newest first; wire copies grouped- edaily.co.krKolon TissueGene Escapes Fourth Limit-Down; Peptron Jumps After Hours[K-Bio Pulse]