FDA regenerative medicine approvals show growing momentum
Published in Drugs development & discovery.
Regenerative medicine offers an innovative approach to treating different indications by restoring damaged or diseased cells and tissues.
Following several years of limited activity, FDA approvals for regenerative medicines have accelerated, culminating in a record eight approvals in 2024. Recent findings also highlighted a surge in regenerative medicine advanced therapy (RMAT) designations, which, together with a robust late-stage pipeline, suggests FDA approval activity for regenerative medicine products is likely to remain elevated in the coming years.
Regenerative medicine offers an innovative approach to treating different indications by restoring damaged or diseased cells and tissues. These therapies address underlying disease mechanisms and have the potential to provide durable clinical benefits, including functional restoration following a single treatment. From 2016 to 2022, FDA approvals for regenerative products remained limited. Over this period, seven drugs received approval, with an average of 1.2 approvals per year.