2020-06-09 15:39:44 MNK Mallinckrodt
06/09/20 06/0915:39 06/09/2015:39 | Mallinckrodt completes rolling submission of BLA of StrataGraft to FDAMallinckrodt announced earlier that Stratatech, a Mallinckrodt company, has completed its rolling submission of a Biologics License Application, or BLA, to the FDA for StrataGraft, a regenerative skin tissue therapy in development for the treatment of adult patients with deep partial-thickness thermal burns. The company previously announced initiation of the rolling submission in April. StrataGraft skin tissue is an investigational product, and its safety and effectiveness have not yet been established by the FDA. |
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