Organogenesis (ORGO) announced the completion of a rolling biologics license application, or BLA, submission to the FDA for ReNu, a cryopreserved, amniotic suspension allograft developed for the management of symptomatic knee osteoarthritis. Organogenesis initiated the rolling BLA submission in December 2025 with non-clinical modules and has now completed the application with the submission of the clinical and chemistry, manufacturing, and controls modules.
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