The FDA has approved a tablet formulation of maralixibat (LIVMARLI) for treating cholestatic pruritus in patients with Alagille syndrome and progressive familial intrahepatic cholestasis.
Researchers found most FDA-authorized COVID-19 treatments were not linked to serious adverse events, though risks may rise with tocilizumab or convalescent plasma in specific patients.
A prefilled syringe version of VYVGART Hytrulo, which enables adult patients with generalized myasthenia gravis or chronic inflammatory demyelinating polyneuropathy to self-administer treatment in as little as 20 to 30 seconds, has been approved by the FDA.
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"This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use."
The FDA approved nivolumab with ipilimumab for unresectable or metastatic microsatellite instability–high or mismatch repair–deficient colorectal cancer.