Hematologic Neoplasms

Breakthrough Real-World Evidence Powering Blood Cancer Research in 2025

4 weeks ago talkbio0Tagged Asymmetric Septal Hypertrophy, hematologic care, Hematologic Neoplasms, real-world evidence, Real-world Evidence, SOHO

RWE; blood cancer; real-world evidence; ASH 2025; SOHO 2025; hematologic care

FDA Signals Higher Efficacy Bar for New CAR‑T Cancer Therapies

1 month ago talkbio0Tagged CAR-T, Cells, Chimeric Antigen Receptor T-Cell Therapy, gene therapy, Hematologic Neoplasms, Neoplasms, Overall Survival, Randomized Controlled Trials as Topic, regulatory standards, superiority trials, United States Food and Drug Administration

FDA; CAR-T; chimeric antigen receptor T-cell therapy; oncology; regulatory standards; superiority trials; randomized controlled trials; overall survival; hematologic malignancies; cell and gene therapy

FDA restricts bluebird bio’s Skysona to CALD patients without suitable stem cell donors after higher blood cancer risk emerges

5 months ago talkbio0Tagged boxed, CALD, Cautionary Warning, Cerebral Adrenoleukodystrophy, Donor person, Elivaldogene autotemcel, gene therapy, Hematologic Neoplasms, HLA Match, label update, Leukemia, Myelocytic, Acute, MYELODYSPLASTIC SYNDROME, Safety, Skysona, United States Food and Drug Administration

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

5 months ago talkbio0Tagged boxed, CALD, Cautionary Warning, Cerebral Adrenoleukodystrophy, Elivaldogene autotemcel, gene therapy, Hematologic Neoplasms, HLA‑matched donor, labeling changes, Leukemia, Myelocytic, Acute, MYELODYSPLASTIC SYNDROME, Safety, Skysona, United States Food and Drug Administration

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