FDA restricts use of bluebird's Skysona gene therapy

FDA restricts use of bluebird's Skysona gene therapy

The FDA has added a warning label to bluebird bio's Skysona, after launching a probe into cases of blood cancer linked to the gene therapy.

Skysona Blood Cancer Side Effects Lead to New FDA Restrictions

Seven additional patients have developed blood cancer on Skysona, since the gene therapy drug first received accelerated approval in 2022. Federal health regulators are requiring the gene therapy drug Skysona to carry new warnings and information about potential blood cancer side effects, indicating patients who take the drug will require life-long medical mo…