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Chronic Myelogenous Leukemia (CML) News

Related terms: Cancer, Chronic Myelogenous Leukemia, Chronic Granulocytic Leukemia, Leukemia, Chronic Granulocytic, CML, Chronic Myeloid Leukemia

FDA Approves Bosutinib for Pediatric Patients with Chronic Myelogenous Leukemia

September 27, 2023 – On September 26, 2023, the Food and Drug Administration approved bosutinib (Bosulif, Pfizer) for pediatric patients 1 year of age and older with chronic phase (CP) Ph+ chronic...

Proteinuria Higher With Dasatinib Exposure in Chronic Myelogenous Leukemia

WEDNESDAY, Sept. 20, 2023 – For patients with chronic myelogenous leukemia (CML) receiving tyrosine-kinase inhibitor therapy, exposure to dasatinib is associated with increased odds of proteinuria,...

FDA Approves Scemblix (asciminib) for the Treatment of Philadelphia Chromosome-Positive Chronic Myeloid Leukemia (Ph+ CML)

Scemblix provides much-needed and long-awaited new option for patients with chronic myeloid leukemia (CML) who suffer with intolerance or inadequate response after at least two previous tyrosine...

FDA Approves Supplemental New Drug Application for Takeda’s Iclusig (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML

December 18, 2020 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application...

Novartis Drug Tasigna Approved by FDA to Treat Children with Rare Form of Leukemia

Basel, March 22, 2018 - Novartis announced today that the US Food and Drug Administration (FDA) expanded the indication for Tasigna (nilotinib) to include treatment of first- and second-line...

FDA Approves Pfizer’s Bosulif (bosutinib) for the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia (CML)

December 19, 2017 – Pfizer Inc. (NYSE:PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indication for Bosulif...

FDA Updates the Label of Tasigna to Reflect that Certain Patients with a Type of Leukemia May be Eligible to Stop Treatment After Sustained Response

December 22, 2017 – The U.S. Food and Drug Administration today updated the product label for the cancer drug Tasigna (nilotinib) to include information for providers about how to discontinue the...

FDA Expands Approval of Sprycel (dasatinib) to Include Treatment of Children with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase

PRINCETON, N.J.--(BUSINESS WIRE) November 10, 2017 --Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel...

FDA Approves U.S. Product Labeling Update for Sprycel (dasatinib) to Include Three-Year First-Line and Five-Year Second-Line Efficacy and Safety Data in Chronic Myeloid Leukemia in Chronic Phase

Data added to Sprycel U.S. labeling are among the longest follow-up data of current CML treatment options PRINCETON, N.J., June 20, 2013--(BUSINESS WIRE)--Bristol-Myers Squibb Company and Otsuka...

FDA Approves Iclusig to Treat Two Rare Types of Leukemia

December 14, 2012 - The U.S. Food and Drug Administration today approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute...

FDA Approves Synribo for Chronic Myelogenous Leukemia

October 26, 2012 - The U.S. Food and Drug Administration today approved Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease. ...

FDA Approves Bosulif for Chronic Myelogenous Leukemia

September 4, 2012 – The U.S. Food and Drug Administration today approved Bosulif (bosutinib) to treat chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older...

FDA approves additional medical indication for Sprycel

SILVER SPRING, Md., Oct. 28 - The U.S. Food and Drug Administration today approved a new indication for Sprycel (dasatinib) for the treatment of a rare blood cancer when it is first diagnosed. The...

Novartis International AG (CH) - FDA approves Tasigna for newly diagnosed chronic myeloid leukemia patients, data demonstrate major advance over Glivec

Basel, June 17, 2010 - Following a priority review, the US Food and Drug Administration (FDA) has approved Tasigna (nilotinib) for the treatment of adult patients with newly diagnosed Philadelphia...

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