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Acute Lymphoblastic Leukemia News (Page 2)
FDA Grants Full Approval for Blincyto (blinatumomab) to Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
Conversion From Accelerated to Full Approval Reinforces Blincyto as Standard of Care for Patients With Minimal Residual Disease at Baseline After Remission THOUSAND OAKS, Calif., June 21, 2023...
Jazz Pharmaceuticals Announces U.S. FDA Approval of Monday/Wednesday/Friday Intramuscular Dosing Schedule for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)
Rylaze dosing options provide sustained asparaginase activity throughout the entire course of treatment for adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma ...
U.S. FDA Approves Kite’s Tecartus as the First and Only CAR-T for Adults with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
SANTA MONICA, Calif.--(BUSINESS WIRE) October 01, 2021 – Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has granted approval for Tecartus® ...
FDA Approves Rylaze for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
DUBLIN, June 30, 2021 /PRNewswire/ – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of Rylaze (asparaginase erwinia chrysanthemi...
Sprycel (dasatinib) Tablets Now Approved in Combination with Chemotherapy in Certain Pediatric Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel ® (dasatinib) tablets to ...
FDA Approves Asparlas (calaspargase pegol-mknl) for Acute Lymphoblastic Leukemia (ALL)
On December 20, 2018, the Food and Drug Administration approved calaspargase pegol-mknl (Asparlas, Servier Pharmaceuticals LLC), an asparagine specific enzyme, as a component of a multi-agent...
FDA Expands Approval of Blincyto (blinatumomab) to Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
March 29, 2018 – The U.S. Food and Drug Administration granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL)...
FDA Approves Genentech’s Actemra (tocilizumab) for the Treatment of CAR T Cell-Induced Cytokine Release Syndrome
South San Francisco, CA – August 30, 2017 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved...
FDA Approves Kymriah (tisagenlecleucel) CAR-T Gene Therapy for Acute Lymphoblastic Leukemia
August 30, 2017 – The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of...
FDA Approves Besponsa (inotuzumab ozogamicin) for Relapsed or Refractory Acute Lymphoblastic Leukemia
August 17, 2017 – The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic...
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 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 Blincyto (blinatumomab) For Use In Pediatric Patients With Philadelphia Chromosome-Negative Relapsed Or Refractory B-cell Precursor Acute Lymphoblastic Leukemia
THOUSAND OAKS, Calif., Sept. 1, 2016 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application...
Jazz Pharmaceuticals Receives FDA Approval For Intravenous Administration Of Erwinaze
DUBLIN, Dec. 19, 2014 /PRNewswire/ – Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) approved the intravenous administration of Erwinaze (asparaginase...
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...