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Leukemia News (Page 4)
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FDA Approves Vyxeos (daunorubicin and cytarabine) Liposome for Injection for Certain Types of Poor-Prognosis Acute Myeloid Leukemia
August 3, 2017 – The U.S. Food and Drug Administration today approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML)...
FDA Approves Idhifa (enasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with IDH2 Mutation
August 1, 2017 – The U.S. Food and Drug Administration today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a...
FDA Grants Full Approval for Blincyto (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children
THOUSAND OAKS, Calif., July 11, 2017 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application...
FDA Approves Rituxan Hycela (rituximab and hyaluronidase human) for Subcutaneous Injection in Certain Blood Cancers
South San Francisco, CA – June 22, 2017 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved Rituxan...
FDA Approves Rydapt (midostaurin) for FLT3-Mutated Acute Myeloid Leukemia and Systemic Mastocytosis
April 28, 2017 – The U.S. Food and Drug Administration today approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific...
FDA Approves Xatmep (methotrexate) Oral Solution
Denver, April 26, 2017 — Silvergate Pharmaceuticals, Inc. leaders in the development and commercialization of innovative and safe medicines for children, today announced that the United States Food a...
FDA Approves Venclexta (venetoclax) for Chronic Lymphocytic Leukemia with 17p Deletion
April 11, 2016 – The U.S. Food and Drug Administration today approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality...
Genmab Announces U.S. FDA Approval of Arzerra (ofatumumab) as Extended Treatment for Recurrent or Progressive CLL
Copenhagen, Denmark; January 19, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (...
FDA Approves Blincyto (blinatumomab) for Precursor B-Cell Acute Lymphoblastic Leukemia
December 3, 2014 – The U.S. Food and Drug Administration today approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia...
FDA Approves Zydelig (idelalisib) for CLL and Lymphoma
July 23, 2014 – The U.S. Food and Drug Administration today approved Zydelig (idelalisib) to treat patients with three types of blood cancers. Zydelig is being granted traditional approval to treat...
FDA Approves Imbruvica (ibrutinib) to Treat Chronic Lymphocytic Leukemia
February 12, 2014 – The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one...
FDA Approves Gazyva for Chronic Lymphocytic Leukemia
November 1, 2013 – The U.S. Food and Drug Administration today approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic...
FDA Medwatch Alert: Iclusig (Ponatinib): Drug Safety Communication - Increased Reports Of Serious Blood Clots In Arteries And Veins
UPDATED 10/31/2013. FDA has asked, and Ariad Pharmaceuticals has agreed, to suspend marketing and sales of Iclusig (ponatinib), a leukemia chemotherapy drug, because of the risk of life-threatening b...
FDA Medwatch Alert: Iclusig (Ponatinib): Drug Safety Communication - Increased Reports Of Serious Blood Clots In Arteries And Veins
ISSUE: FDA is investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels (arteries and veins) of patients taking the leukemia ...
FDA Approves Gleevec for Children with Acute Lymphoblastic Leukemia
January 25, 2013 – The U.S. Food and Drug Administration today approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute...
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Chronic Myelogenous Leukemia (CML), Chronic Lymphocytic Leukemia (CLL), Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Hairy Cell Leukemia, Blood Disorders