Health news
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…
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…
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,…
The Food and Drug Administration (FDA) has withdrawn the approval of Ukoniq (umbralisib) for the treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL).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)…
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…
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…
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…
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…
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…
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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