> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA OKs Janssen’s Tremfya One Press Injector
- URL: https://www.fdaweb.com/fda-oks-janssens-tremfya-one-press-injector/
- Published: 2019-02-28T12:00:00.000Z
- Updated: 2026-09-15T01:08:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143493

FDA has approved a Janssen Pharmaceutical supplemental BLA for Tremfya (guselkumab) One-Press, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis. The company says One-Press offers a controlled injection that hides the needle throughout the process. Approval was based on results from the Phase 3 ORION study that evaluated patient experience with One-Press through a validated Self-Injection Assessment Questionnaire. The majority of injection-site reaction symptoms with One-Press were mild and transient in nature, the company says.