Mallinckrodt StrataGraft Skin Therapy Could Be The First RMAT-Designated Therapy Approved By US FDA

The company presented positive data from a Phase III pivotal trial during the American Burn Association virtual annual meeting.

Regenerative Agriculture, Holistic Management, farming problem concept. Yellow field with a blue sky and a green forest with grass.
Stratagraft is designed to regrow living tissue

Mallinckrodt PLC's StrataGraft – a regenerative skin tissue therapy – appears closer to reaching the market after a long development road. The company announced on 9 June that it completed a rolling Biologics License Application for StrataGraft with the US Food and Drug Administration for the treatment of adult patients with deep partial-thickness (DPT) burns.

The pivotal Phase III trial supporting the submission was also presented at the virtual American Burn Association (ABA) annual meeting...

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