News / Announcements
June 30, 2026: The PRCSG and CARRA are collaborating to initiate the convening and planning of an FDA Workshop: Accelerating Product Development for Pediatric Systemic Lupus Erythematosus (SLE). The workshop, which is co-hosted by the FDA and the Center of Excellence in Regulatory Science and Innovation, will be at the FDA in Silver Spring, Maryland on July 30-31. Registration is free and this event is also available virtually. You are cordially invited to register here.
September 29, 2025: FDA approves TREMFYA® for the treatment of pediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor
June 28, 2025: FDA approves Gamifant® (emapalumab-lzsg) as first-ever treatment for adults and children with Macrophage Activation Syndrome in Still’s disease (including systemic Juvenile Idiopathic Arthritis (sJIA).
Brunner, H.I., Antón, J., Calvo-Penadés, I., Dimelow, R., Horneff, G., Kamphuis, S., Marino, R., van Maurik, A., Minden, K., Mori, M., Ocran-Appiah, J., Wilkinson, C., Yamasaki, Y., Assudani, D. and for the Pediatric Rheumatology Collaborative Study Group (PRCSG) and Paediatric Rheumatology International Trials Organisation (PRINTO) network investigators (2025), Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Belimumab in Pediatric Patients with Systemic Lupus Erythematosus: A Multicenter, Open-Label Trial. Arthritis Care Res. Accepted Author Manuscript. https://doi.org/10.1002/acr.25700
Shishov M, Weiss PF, Levy DM, Chang JC, Angeles-Han ST, Ogbu EA, Nanda K, Sherrard TM, Goldmuntz E, Lovell DJ, Rider LG, Brunner HI; of the PRCSG Advisory Council.
Arthritis Care Res (Hoboken). 2024 Dec 9. https://doi.org/10.1002/acr.25482 Epub ahead of print. PMID: 39651592.