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FDA grants breakthrough status to new blood cancer drug, iopofosine I 131, after successful trials.
The FDA has granted breakthrough therapy designation to a new drug, iopofosine I 131, for treating relapsed/refractory Waldenström macroglobulinemia, a type of blood cancer.
This decision follows phase 2 trial data showing an overall response rate of 83.6%.
Cellectar Biosciences, the drug's developer, is now seeking approval in Europe and saw its stock surge by 71% in pre-market trading.
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La FDA otorga el estatus de avance a un nuevo medicamento contra el cáncer de sangre, la iopofosina I 131, después de ensayos exitosos.