Organogenesis announces FDA acceptance of ReNu biologics license application
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.
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08:15:58 PM UTC
SquawkNews
Organogenesis (ORGO) said late Monday that the US Food and Drug Administration accepted the company's biologics license applications related to ReNu for review. The cryopreserved allograft is designed to treat pain in knee osteoarthritis, according to the company. The FDA has set a prescription drug user fee act target action date of April 24, 2027, according to a statement.
Organogenesis (ORGO) said late Monday that the US Food and Drug Administration accepted the company's biologics license applications related to ReNu for review.
The cryopreserved allograft is designed to treat pain in knee osteoarthritis, according to the company.
The FDA has set a prescription drug user fee act target action date of April 24, 2027, according to a statement.