Organogenesis Begins FDA Rolling Review for ReNu Biologics License Application

Reuters

Dec 24, 2025

Organogenesis Begins FDA Rolling Review for ReNu Biologics License Application

Organogenesis Holdings Inc. has initiated a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ReNu®, a cryopreserved, amniotic suspension allograft developed for the management of symptomatic knee osteoarthritis. The company plans to complete the BLA submission with the final modules expected in the first half of 2026. ReNu has previously received the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for knee osteoarthritis.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Organogenesis Holdings Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9616768-en) on December 23, 2025, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

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The company plans to complete the BLA submission with the final modules expected in the first half of 2026. ReNu has previously received the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for knee osteoarthritis.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Organogenesis Holdings Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. 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