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FDA
Biotech
'Unprecedented' data prime Kyverna for 1st autoimmune CAR-T drug
Kyverna's CD19 CAR-T showed “unprecedented” results doctors have never seen with existing off-label therapies, the lead study investigator said.
Angus Liu
Dec 15, 2025 10:55am
Immunome's desmoid tumor treatment triumphs in phase 3
Dec 15, 2025 10:42am
Sanofi's tolebrutinib woes pile up with FDA delay, trial miss
Dec 15, 2025 9:30am
GAO finds FDA staffing shortfalls delaying device recall work
Dec 12, 2025 3:10pm
Gone are the bear days for biotech? William Blair thinks so
Dec 12, 2025 10:55am
HeartBeam swells on turning FDA rejection into ECG clearance
Dec 11, 2025 11:50am
