FDA Restricts Gene Therapy Skysona Due to Blood Cancer Risk

FDA Restricts Gene Therapy Skysona Due to Blood Cancer Risk

(MedPage Today) -- The FDA approved labeling changes for elivaldogene autotemcel (eli-cel; Skysona), a one-time gene therapy for patients with early, active cerebral adrenoleukodystrophy (CALD), to reflect new safety information about hematologic...

FDA restricts use of bluebird's gene therapy Skysona due to increased blood cancer risk

The FDA is restricting the use of bluebird bio's rare neurologic disease gene therapy Skysona after the number of cancer diagnoses linked to use of the treatment increased substantially in clinical trial participants since its ...