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 […]
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 […]
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) […]
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 […]
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 […]
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 […]
On August 13, 2024, the US Food and Drug Administration (FDA) approved nemolizumab for the treatment of adults with prurigo nodularis (PN). A first-in-class monoclonal antibody […]
The US Food and Drug Administration (FDA) has approved palopegteriparatide (Yorvipath) for the treatment of hypoparathyroidism in adults, the drug’s manufacturer Ascendis Pharma announced. In hypoparathyroidism, […]
The US Food and Drug Administration (FDA) has declined to approve a treatment that combines the psychedelic drug midomafetamine with assisted therapy (MDMA-AT) for the treatment […]
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