US regulators’ use of a speedy clearance pathway for a new frontline indication for asciminib for chronic myeloid leukemia (CML) has raised questions due to the number of medications already available ...

The major molecular response rate was 68% with asciminib and 49% with IS-TKIs (difference, 19% [95% CI, 10-28]; P .001). The Food and Drug Administration (FDA) has granted accelerated approval to ...

(RTTNews) - Novartis (NVS) announced that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration for adult patients with newly diagnosed Philadelphia ...

Novartis (NVS) announced that Scemblix was granted accelerated approval by the U.S. Food and Drug Administration for adult patients with newly diagnosed Philadelphia chromosome-positive chronic ...

Bosutinib approved for chronic myelogenous leukemia The FDA has approved bosutinib (Bosulif, Pfizer) for patients with chronic, accelerated or blast phase Philadelphia chromosome positive CML, who are ...