Steqeyma is now supplied as a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection for pediatric patients weighing less than 60kg. The Food and Drug Administration (FDA) has approved a ...
Please provide your email address to receive an email when new articles are posted on . AUSTIN, Texas — Real-world dose escalation of Stelara was safe and effective in patients with perianal Crohn’s ...
The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentations matching the reference product, effective as of April ...
On May 22, 2025, the FDA approved Bio-Thera Solutions and Hikma Pharmaceuticals’ ustekinumab biosimilar, STARJEMZA® (ustekinumab-hmny) injection, referencing Janssen’s STELARA® (ustekinumab) injection ...
The approval was based on a comprehensive review of scientific evidence that showed the product was highly similar to Stelara. This included data from the phase 3 VESPUCCI study (ClinicalTrials.gov ...
African American doctor talking to patient in office Researchers sought to identify predictive markers of ustekinumab response as well as evaluate the effect of its pharmacokinetics on the clinical ...
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