Johnson & Johnson seeks U.S. FDA approval for subcutaneous induction regimen of TREMFYA® (guselkumab) in ulcerative colitis, a first for an IL-23 inhibitor [Yahoo! Finance]
Johnson & Johnson (JNJ)
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Source: Yahoo! Finance
its potential to be the only IL-23 inhibitor that offers choice of subcutaneous or intravenous induction in UC Submission is supported by the Phase 3 ASTRO study, which achieved the primary endpoint of clinical remission at Week 12 and met all secondary endpoints in adults with moderately to severely active UC SPRING HOUSE, Pa. Nov. 22, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a subcutaneous (SC) induction regimen of TREMFYA ® (guselkumab) for the treatment of adults with moderately to severely active UC. The filing is supported by data from the Phase 3 ASTRO study of TREMFYA ® SC induction therapy in adults with UC and builds upon the recent U.S. approval of TREMFYA ® in this indication. The Phase 3 ASTRO study met its primary endpoint, achieving a statistically significant and clinically meaningful results for clinic
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JNJ
Earnings
- 10/15/24 - Beat
JNJ
Sec Filings
- 11/13/24 - Form 13F-HR
- 11/6/24 - Form 25-NSE
- 10/31/24 - Form 4/A
- JNJ's page on the SEC website