Hematologic Neoplasms
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
Blood cancer biotech Vor Bio ends clinical work, lays off 95% of staff
Hematologic Neoplasms, Leukemia, Myelocytic, Acute, Reflex, Vestibulo-Ocular, gene therapy, 95%
Umoja Biopharma Advances In Situ CAR-T Therapy with FDA Clearance and $100M Series C Funding
Umoja Biopharma, CAR-T therapy, in situ, UB-VV111, FDA clearance, hematologic malignancies, Series C funding
FDA Rejects Regeneron’s Blood Cancer Bispecific, Delaying Competition with J&J and Pfizer
Regeneron, FDA rejection, blood cancer bispecific, linvoseltamab, multiple myeloma, J&J, Pfizer
Geron Corporation Loses Chief Commercial Officer Following FDA Approval of RYTELO
Geron Corporation, Chief Commercial Officer, FDA Approval, RYTELO, Blood Cancer Treatment
Gilead’s Magrolimab Linked to Increased Risk of Death in Blood Cancer Patients
Gilead, Magrolimab, Blood Cancer, Increased Risk of Death, ENHANCE Study
Geron’s Rytelo Receives FDA Approval for Lower-Risk Myelodysplastic Syndromes Treatment
Geron, Rytelo, FDA Approval, Blood Cancer, Myelodysplastic Syndromes, Telomerase Inhibitor, Imetelstat
Sanofi’s BTK Inhibitor Succeeds in Phase 3 LUNA Trial, Accelerating Regulatory Approval Race
Sanofi, BTK inhibitor, LUNA trial, phase 3, regulatory approval, clinical development, blood cancer, competition