Posted by Michael Wonder on 24 Dec 2025
Organogenesis announces initiation of biologics license application for ReNu
23 December 2025 - Initial modules submitted to FDA under rolling review; final modules expected in the first half of 2026
Organogenesis today announced the initiation of a rolling submission of a biologics license application to the FDA for ReNu, a cryopreserved, amniotic suspension allograft developed for the management of symptomatic knee arthritis.
Organogenesis plans to complete the biologics license application submission with the final modules submitted in the first half of 2026.
