Organogenesis Begins FDA Rolling Review for ReNu Biologics License Application

Reuters
2025.12.23 21:05
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Organogenesis Holdings Inc. has started a rolling submission of a Biologics License Application to the FDA for ReNu®, aimed at treating knee osteoarthritis. The submission is expected to be completed by mid-2026. ReNu has received the FDA’s RMAT designation. The news was originally published by Organogenesis via GlobeNewswire on December 23, 2025.