FDA Considering Pulling Gene Therapy From Market After Deaths: Commissioner

Regulators are ’taking a hard look' at the matter, Dr. Marty Makary said.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The Food and Drug Administration (FDA) may revoke authorization for a gene therapy for which multiple deaths have been reported, the agency’s commissioner said on July 18.

The FDA is “taking a hard look” at whether Sarepta Therapeutics’ Elevidys should remain on the market, Dr. Marty Makary told Bloomberg.