Krazati is a highly selective and potent oral small molecule inhibitor of KRASG12C.
The MWF dosing option was approved under the Real-Time Oncology Review program based on data from the intramuscular administration part of a phase 2/3 trial.
Epcoritamab is designed to bind to CD3 on T cells and CD20 on B cells, inducing T cell mediated killing of CD20+ cells.
The decision to restrict the indication follows an FDA review of the double-blind, placebo-controlled phase 3 ENGOT-OV16/NOVA trial.
The approval was based on data from the SORAYA trial.
The approval was based on data from the MajesTEC-1 study which included 110 adults with relapsed or refractory multiple myeloma who had previously received ≥3 prior therapies.
Pedmark is the first FDA-approved therapy indicated to reduce the risk of cisplatin-induced hearing loss in children.
SKOUT is designed to recognize suspicious tissue and provide real-time feedback to gastroenterologists.
The approvals were based on data from the LIBRETTO-001 trial.
Besremi is a monopegylated, long-acting interferon, which exhibits its cellular effects in the bone marrow in polycythemia vera.
