July 22, 2018 – The American Food and Drug Administration (FDA) just approved Ivosidenib (Tibsovo) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation in the IDH1 gene.  It is …

Ivosidenib (Tibsovo) for AML-patients with IDH1-mutations Read more »

August 02, 2017 – This is another cornerstone in the fight against acute myeloid leukemia (AML): The American Food and Drug Administration (FDA) just approved Enasidenib (Idhifa) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia …

Enasidenib (Idhifa): Targeted treatment for relapsed or refractory AML Read more »

  April 30, 2017 – The American Food and Drug Administration (FDA) just approved Midostaurin (Rydapt) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who carry particular genetic mutations in the FLT3 (CD135) gene, in combination …

LeukoStrat CDx FLT3 Mutation Assay: New entry in the field of companion tests Read more »

June 21, 2010 –  FDA notified healthcare professionals that results from a recent clinical trial raised new concerns about the product’s safety, and the drug failed to demonstrate clinical benefit to patients enrolled in trials. Background: Gemtuzumab Ozogamicin [Mylotarg], indicated …

Gemtuzumab Ozogamicin [Mylotarg]: Market Withdrawal Read more »