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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
American Society of Hematology, Dec. 7 to 10
The annual meeting of the American Society of Hematology was held from Dec. 7 to 10 in San Diego and attracted participants from around the world, including hematology specialists as well as clinical ...
FDA Approves Imkeldi (imatinib) Oral Solution for the Treatment of Certain Forms of Leukemia and Other Cancers
CAMBRIDGE, Mass.-- November 25, 2024 --Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the FDA has approved Imkeldi (imatinib) oral solution, the fir...
FDA Approves Danziten (nilotinib) Tablets, the First and Only Nilotinib With No Mealtime Restrictions
WOBURN, Mass. Nov 14, 2024 – Azurity Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved Danziten, the first and only nilotinib with no mealtime restrictions ...
Novartis Scemblix Granted FDA Accelerated Approval in Newly Diagnosed CML
East Hanover, October 29, 2024 – Novartis announced today that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly d...
ASCO: Asciminib Has Superior Efficacy to TKIs for Newly Diagnosed Leukemia
WEDNESDAY, June 5, 2024 – For patients with newly diagnosed chronic myeloid leukemia (CML), asciminib shows superior efficacy and a favorable safety profile compared with investigator-selected...
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...
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. ...