FDA Approves Wezlana, First Interchangeable Biosimilar to Stelara

FDA Approves Wezlana, First Interchangable Biosimilar to Stelara

The U.S. Food and Drug Administration (FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara for adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn’s disease; and moderately to severely active ulcerative colitis.

First Treatment Approved for Genetic Clotting Disorder

The U.S. Food and Drug Administration has approved a recombinant ADAMTS13 protein product (Adzynma) as a prophylactic or on-demand enzyme replacement therapy for patients with congenital thrombotic thrombocytopenic purpura.

First Vaccine for Mosquito-Born Viral Disease Is Approved by FDA

The U.S. Food and Drug Administration has approved IXCHIQ, Valneva’s single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.