Novel 12-LOX Inhibitor Fast Tracked for Heparin-Induced Thrombocytopenia
VLX-1005 is a first-in-class, selective small molecule inhibitor of 12-lipoxygenase, a key target within the arachidonic acid pathway.
Diagnosis & Disease Information
Beti-Cel, a Gene Therapy for Beta-Thalassemia, Gets FDA Panel Support
Beti-cel is an investigational one-time gene therapy that works by adding functional copies of a modified form of the beta-globin gene into a patient’s own hematopoietic stem cells.
Bristol Myers Squibb Withdraws Luspatercept sBLA for NTD Beta Thalassemia
The application included data from the phase 2 BEYOND study.
FDA Withdraws Approval of Ukoniq Over Safety Concerns
Updated findings from the UNITY-CLL trial continue to show a possible increased risk of death among patients who received Ukoniq.
Fylnetra, a Biosimilar to Neulasta, Gets FDA Approval
The approval was based on data demonstrating a high degree of similarity of Fylnetra to the reference product, with no clinically meaningful differences.
Takhzyro Prefilled Syringe Now Available for Patients With Hereditary Angioedema
The prefilled syringe is provided as a 300mg/2mL (150mg/mL) ready-to-use solution for subcutaneous injection and does not require additional reconstitution or dilution.
Once-Weekly Efanesoctocog Alfa Prevents Bleeding Episodes in Hemophilia A Trial
The phase 3 XTEND-1 study evaluated efanesoctocog alfa in 159 patients with severe hemophilia A who were previously treated with factor VIII replacement therapy.
New Dosing Regimen Approved for Gazyva in Follicular Lymphoma
For patients with follicular lymphoma who do not experience a grade 3 or higher IRR during Cycle 1, Gazyva may now be administered as a 90-minute infusion.
FDA: Safety Concerns With Lymphoma Drug Ukoniq
An initial review of data from the phase 3 UNITY trial in CLL patients showed the combination of Ukoniq and ublituximab was associated with increased risk of death compared with the control arm.
Vonvendi Approved for Severe Type 3 von Willebrand Disease
Results showed the median ABR for all bleeds was reduced by 54.7%.
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