label update – Talk Bio

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

1 month 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 Approves Updated Dosing for Lilly’s Kisunla to Lower Brain Swelling Risk

2 months ago talkbio0Tagged Alzheimer 's disease, Cerebral Edema, dosing, eli lilly, Kisunla, label update, Neuregulins, Safety, Treatment Protocols, United States Food and Drug Administration

FDA; Kisunla; Eli Lilly; Alzheimer’s disease; dosing regimen; brain swelling; ARIA; safety; label update; TRAILBLAZER-ALZ 6

FDA Updates Label for Agios’ PYRUKYND with New Liver Injury Warning

8 months ago talkbio0Tagged Agios, Cautionary Warning, Injury of liver, label update, Pyrukynd, Thalassemia, United States Food and Drug Administration

Agios Pharmaceuticals, PYRUKYND, mitapivat, liver injury warning, FDA label update, thalassemia treatment