FDA Extends Review Period for Valoctocogene Roxaparvovec for Hemophilia A
Valoctocogene roxaparvovec is an investigational adeno-associated virus (AAV) gene therapy.
Valoctocogene roxaparvovec is an investigational adeno-associated virus (AAV) gene therapy.
The Lucira COVID-19 & Flu Home test is a single-use, nucleic acid amplification test intended for individuals with signs and symptoms consistent with a respiratory tract infection.
Altuviiio temporarily replaces the missing coagulation factor VIII needed for effective hemostasis.
Elranatamab is a B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody.
Crovalimab achieved disease control in patients with paroxysmal nocturnal hemoglobinuria who have not been previously treated with complement inhibitors.
The approval was based on data from the phase 3 SEQUOIA and ALPINE studies in patients with CLL/SLL.
Lumoxiti was approved by the FDA in September 2018 for the treatment of adults with relapsed or refractory hairy cell leukemia.
Actemra (tocilizumab) is an interleukin-6 receptor antagonist.
The recall affects a total of 11,102 Detect tests.
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody that targets CD20 on the surface of B cells and CD3 on the surface of T cells.