September 16, 2024
The US Food and Drug Administration (FDA) has approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) as a subcutaneous injection in adults, covering all approved indications […]
September 14, 2024
The US Food and Drug Administration (FDA) has approved the targeted interleukin (IL)-13 inhibitor lebrikizumab (Ebglyss) for the treatment of adults and children age 12 years […]
September 13, 2024
The US Food and Drug Administration (FDA) has approved a subcutaneous formulation of the anti-CD20 antibody ocrelizumab (Ocrevus Zunovo, Genentech) for the treatment of relapsing multiple […]
August 21, 2024
The US Food and Drug Administration (FDA) has declined to approve linvoseltamab (Regeneron), a bispecific antibody being evaluated to treat relapsed/refractory multiple myeloma after progression on […]
August 20, 2024
The US Food and Drug Administration (FDA) has approved lazertinib (Lazcluze) in combination with amivantamab-vmjw (Rybrevant) for upfront treatment of adults with locally advanced or metastatic […]
August 16, 2024
The US Food and Drug Administration (FDA) has approved durvalumab (Imfinzi; AstraZeneca) both before and after surgery in patients with resectable non–small cell lung cancer (NSCLC) […]
August 14, 2024
The US Food and Drug Administration (FDA) has approved axatilimab (Niktimvo, Incyte Corporation) for the treatment of adult and pediatric patients with chronic graft versus host […]
August 14, 2024
The US Food and Drug Administration (FDA) granted accelerated approval for Livdelzi (seladelpar, Gilead Sciences, Inc.) for primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid […]
August 14, 2024
The European Commission has approved a combination of an immunotherapy agent with a poly (ADP-ribose) polymerase (PARP) inhibitor for the treatment of certain patients with primary […]