FDA Center for Biologics Evaluation and Research

New Capabilities

Reviewed the Voceryq biologics license application

Adults with recurrent respiratory papillomatosis (RRP) have had one treatment: surgery to shave HPV-grown warts off the vocal cords and airway, often several times a year. On October 30, 2026, the Food and Drug Administration granted accelerated approval to Voceryq, an injected DNA-based immunotherapy meant to reduce how often those operations are needed.

Updated 7 days ago

New Capabilities

Reviewing gene therapy approvals and safety

Regenxbio's RGX-202 met the main goal of its AFFINITY DUCHENNE trial in May 2026. In 93% of treated boys with usable biopsies, muscle made microdystrophin, a shortened form of the missing protein, at more than 10% of normal levels by week 12. The company finished dosing a confirmatory study and plans to file for FDA approval in the third quarter of 2026.

Updated Nov 1

New Capabilities

As of May 2026: Reviewing cardiac regeneration therapies for clinical approval

Researchers just demonstrated they can regenerate heart muscle using reprogrammed stem cells—and for the first time, proved these patches work in a human patient. In January 2025, a 46-year-old woman with advanced heart failure received 10 patches containing 400 million stem cell-derived heart muscle cells. Three months later, when she received a transplant, examination of her original heart revealed the patches had survived, formed blood vessels, and integrated with her heart tissue.

Updated May 21