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Novel 12-LOX Inhibitor Fast Tracked for Heparin-Induced Thrombocytopenia > Hematologic Disorders

Category: Hematologic Disorders

Novel 12-LOX Inhibitor Fast Tracked for Heparin-Induced Thrombocytopenia
General Hematologic Disorders Hematology News Thromboembolic Disorders

Novel 12-LOX Inhibitor Fast Tracked for Heparin-Induced Thrombocytopenia

Steve Duffy June 15, 2022

The Food and Drug Administration (FDA) has granted Fast Track designation to VLX-1005 for the treatment and prevention of heparin-induced thrombocytopenia and thrombosis. VLX-1005 is a first-in-class, selective small molecule inhibitor of 12-lipoxygenase, a key…

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Beti-Cel, a Gene Therapy for Beta-Thalassemia, Gets FDA Panel Support
Anemias General Hematologic Disorders Hematology News

Beti-Cel, a Gene Therapy for Beta-Thalassemia, Gets FDA Panel Support

Steve Duffy June 13, 2022

The Food and Drug Administration (FDA)’s Cellular, Tissue, and Gene Therapies Advisory Committee voted in favor of the approval of betibeglogene autotemcel (beti-cel) for patients with beta-thalassemia who require regular red blood cell transfusions. Beti-cel…

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Bristol Myers Squibb Withdraws Luspatercept sBLA for NTD Beta Thalassemia
Anemias General Hematologic Disorders Hematology News

Bristol Myers Squibb Withdraws Luspatercept sBLA for NTD Beta Thalassemia

Top-Meds June 6, 2022

Bristol Myers Squibb announced the withdrawal of the supplemental Biologics License Application (sBLA) for luspatercept-aamt, an erythroid maturation agent, for the treatment of anemia in adults with nontransfusion dependent (NTD) beta thalassemia. In December 2021,…

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FDA Withdraws Approval of Ukoniq Over Safety Concerns
General Hematologic Disorders Leukemias/lymphomas/ And Other Hematologic Cancers News Oncology

FDA Withdraws Approval of Ukoniq Over Safety Concerns

Top-Meds June 2, 2022

The Food and Drug Administration (FDA) has withdrawn the approval of Ukoniq (umbralisib) for the treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL). Ukoniq is an oral inhibitor of phosphoinositide 3 kinase (PI3K)…

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Fylnetra, a Biosimilar to Neulasta, Gets FDA Approval
General Hematologic Disorders News

Fylnetra, a Biosimilar to Neulasta, Gets FDA Approval

Top-Meds May 31, 2022

The Food and Drug Administration (FDA) has approved Fylnetra (pegfilgrastim-pbbk), a biosimilar to Neulasta® (pegfilgrastim). Fylnetra, a leukocyte growth factor, is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid…

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Takhzyro Prefilled Syringe Now Available for Patients With Hereditary Angioedema
General Hematologic Disorders News

Takhzyro Prefilled Syringe Now Available for Patients With Hereditary Angioedema

Steve Duffy April 18, 2022

Takhzyro® (lanadelumab-flyo) is now available in a prefilled syringe formulation for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older.  The prefilled syringe is provided as a 300mg/2mL…

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Once-Weekly Efanesoctocog Alfa Prevents Bleeding Episodes in Hemophilia A Trial
General Hematologic Disorders News

Once-Weekly Efanesoctocog Alfa Prevents Bleeding Episodes in Hemophilia A Trial

Steve Duffy March 9, 2022

Topline results were announced from a phase 3 study evaluating the efficacy and safety of efanesoctocog alfa (BIVV001) in patients 12 years of age and older with severe hemophilia A previously treated with factor VIII…

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New Dosing Regimen Approved for Gazyva in Follicular Lymphoma

Steve Duffy February 16, 2022

The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Gazyva (obinutuzumab) to include a new dosing regimen for patients with follicular lymphoma (FL) who have completed 3 administrations of…

FDA: Safety Concerns With Lymphoma Drug Ukoniq

Steve Duffy February 4, 2022

The Food and Drug Administration (FDA) is alerting health care professionals and patients about a possible increased risk of death with the lymphoma medication Ukoniq (umbralisib). Ukoniq is an oral inhibitor of phosphoinositide 3 kinase…

Vonvendi Approved for Severe Type 3 von Willebrand Disease

Steve Duffy February 1, 2022

The Food and Drug Administration (FDA) has approved Vonvendi® (von Willebrand factor [recombinant]) for routine prophylaxis to reduce the frequency of bleeding episodes in adults 18 years of age and older with severe Type 3…

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