boxed
FDA restricts bluebird bio’s Skysona to CALD patients without suitable stem cell donors after higher blood cancer risk emerges
FDA; bluebird bio; Skysona; elivaldogene autotemcel; eli-cel; cerebral adrenoleukodystrophy; CALD; hematologic malignancies; myelodysplastic syndrome (MDS); acute myeloid leukemia (AML); boxed warning; label update; postmarketing safety; HLA-matched donor; gene therapy safety
FDA tightens Skysona label, restricting use to CALD patients without alternative options due to increased blood cancer risk
FDA; bluebird bio; Skysona; elivaldogene autotemcel; labeling changes; boxed warning; hematologic malignancy; myelodysplastic syndrome; acute myeloid leukemia; cerebral adrenoleukodystrophy; CALD; HLA‑matched donor; gene therapy safety; post‑marketing reports
FDA Issues Boxed Warning for Anaphylaxis Risk with Multiple Sclerosis Drugs Copaxone and Glatopa
FDA, boxed warning, anaphylaxis, multiple sclerosis, Copaxone, Glatopa, glatiramer acetate, Teva, Sandoz
FDA Adds Boxed Warning to Teva’s Copaxone and Generic Glatopa Due to Anaphylaxis Risk
FDA Boxed Warning, Anaphylaxis Risk, Copaxone, Glatopa, Glatiramer Acetate, Multiple Sclerosis (MS) Treatment, Allergic Reaction
FDA Mandates Enhanced Safety Warnings for CAR-T Therapies Due to Secondary Cancer Risks
CAR-T therapy, secondary cancers, FDA boxed warnings, T-cell malignancies, BCMA-directed, CD19-directed, autologous CAR T-cell immunotherapies.