ORGO News & Events

Organogenesis announced that the FDA has completed their filing determination and accepted for review the company's biologics license application, or BLA, for ReNu, a cryopreserved, amniotic suspension allograft developed for the treatment of pain in symptomatic knee osteoarthritis. The FDA has set a Prescription Drug User Fee Act target action date of April 24, 2027.

Organogenesis 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.