United Therapeutics’ Liver Assist Product Earns FDA Regenerative Medicine Advanced Therapy Designation

▤ Summary

United Therapeutics’ investigational liver support product, miroliver ELAP, received FDA Regenerative Medicine Advanced Therapy designation. The designation can speed development and regulatory review for therapies aimed at serious conditions with unmet medical needs. The product uses a bioengineered liver outside the body to provide temporary support for acute liver failure patients. The company also says it is developing a bioengineered kidney using similar technology. This update signals continued progress in regenerative medicine and organ support products, but the therapy remains investigational.

▦ Linked Companies