The FDA has approved a supplemental indication for lumateperone to reduce relapse risk in adults with schizophrenia based on phase 3 randomized withdrawal data.
The FDA has granted full approval for the use of brexucabtagene autoleucel in adults with relapsed or refractory mantle cell lymphoma, based on confirmatory ZUMA-2 data.
The FDA has approved icotrokinra, an oral interleukin-23 receptor antagonist, for patients aged 12 years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or...
The FDA has approved sotatercept-csrk, the first activin signaling inhibitor therapy, for the management of patients with pulmonary arterial hypertension (PAH). Based on the Phase 3 STELLAR trial,...
Earlier this year, the FDA approved the same vaccine for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
A Janus kinase inhibitor was approved for the treatment of active polyarticular course juvenile idiopathic arthritis among patients aged 2 years or older.