For how we live.
The FDA logged a Class I recall of Instrumentation Laboratory's HemosIL AcuStar HIT assay on 21 October. Certain lots can read up to 47% low, risking a missed diagnosis of heparin-induced thrombocytopenia.
The FDA cleared a dosing change on 16 October for indolent systemic mastocytosis: after at least six months on 25 mg a day, patients may go to 50 mg. A trial extension backs the option.
ESO-T01 builds cancer-killing T cells inside the body, skipping the cell harvest and chemo prep normal CAR-T needs. All four responded — but the cells faded, and median progression-free survival was 4 months.
ITACS randomised 955 anaemic adults to intravenous iron or placebo before elective cardiac surgery. Fewer patients needed a transfusion, but the primary benefit was a median of one day alive and at home.
27 of 28 patients had no severe pain crises after treatment with reni-cel. But the sponsor ended the study early, and the reported analysis was not the one it was designed to test.