Health news
Gilead Sciences has voluntarily withdrawn the US indications for Zydelig® (idelalisib) for the treatment of relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL). In 2014, Zydelig received accelerated approval for these…
Positive 2-year data were announced from a phase 3 study evaluating valoctocogene roxaparvovec, an investigational adeno-associated virus (AAV) gene therapy, in adults with severe hemophilia A. The open-label, single-arm GENEr8-1 study (ClinicalTrials.gov Identifier: NCT03370913) is…
The Food and Drug Administration (FDA) has expanded the approval of Injectafer® (ferric carboxymaltose injection) to include patients 1 year of age and older with iron deficiency anemia (IDA) who have either intolerance to oral…
The Food and Drug Administration (FDA) has approved the supplemental New Drug Application for Siklos (hydroxyurea) to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric…
Sandoz has initiated a recall of 1 lot of Enoxaparin Sodium Injection, USP 40mg/0.4 mL single-dose syringes to the consumer level due to temperature excursion during shipment. Enoxaparin sodium injection is a low molecular weight…
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application for luspatercept-aamt, an erythroid maturation agent, for the treatment of anemia in adults with nontransfusion dependent (NTD) beta thalassemia.…
The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Omeros Corporation regarding the Biologics License Application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).…
The Food and Drug Administration has approved Tecartus® (brexucabtagene autoleucel) for the treatment of adult patients 18 years of age and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Tecartus is an…
The Food and Drug Administration has approved Jakafi® (ruxolitinib) for the treatment of chronic graft-versus-host disease (GVHD) after failure of 1 or 2 lines of systemic therapy in patients 12 years of age and older.…
The Food and Drug Administration has accepted for Priority Review the supplemental New Drug Application (sNDA) for voxelotor (Oxbryta®) for the treatment of sickle cell disease in patients aged 4 to 11 years, along with…
© 2005-2021 Top-Meds - All rights reserved. Our website services, content, and products are for informational purposes only. Top-Meds does not provide medical advice, diagnosis, or treatment. | Medical News 2021