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  1. Mesoblast announced it is seeking accelerated approval in the US via a BLA filing with the FDA.

Mesoblast is seeking FDA review of the BLA for its product rexlemestrocel-L.

3 reports, 1 independent Updated Oct 1
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What happened

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Mesoblast is seeking FDA review of the BLA for its product rexlemestrocel-L.

Who's involved

What this event is mainly about
MesoblastFDA

How it developed

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  1. Mesoblast CEO Silviu Itescu led the company in seeking a positive meeting with the FDA.1 source
  2. FDA approved a new potency assay for product lots from Mesoblast.Sub-event
  3. Mesoblast filed a BLA for rexlemestrocel-L with the FDA for review.1 source

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Mesoblast announced it is seeking accelerated approval in the US via a BLA filing with the FDA. All 1 developments

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