Mesoblast announced it is seeking accelerated approval in the US via a BLA filing with the FDA.
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Updated sep 24
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What happened
Mesoblast announced it is seeking accelerated approval in the US via a BLA filing with the FDA.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.- Mesoblast is seeking FDA review of the BLA for its product rexlemestrocel-L.Sub-event
- Mesoblast is pursuing accelerated approval in the US through a BLA filing with the FDA.
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The entities involved
Related events
- Arise is seeking FDA approval for a drug as of October 7, 2026.
- Immuron anticipates receiving FDA approval for its IND submission.
- Mesoblast and BioXcel Therapeutics, both small-cap healthcare companies, were compared, with Mesoblast outperforming BioXcel on 9 factors.
- FDA accepts a BLA for biosimilar review and extends its review process to Health Canada.
- The FDA is reviewing the BLA submission from Ultragenyx Pharmaceutical, with Eric Crombez serving as chief medical officer.
Coverage
Newest first; wire copies grouped- Unknown outlet