FDA Accepts Supplement for STELARA (Ustekinumab) by Centocor Ortho Biotech
The FDA has accepted a supplemental application for STELARA (ustekinumab) from Centocor Ortho Biotech.
Published: July 27, 2026
Updated: July 27, 2026
Author: Humanexa Intelligence
Therapeutic area: Immunology / IL-12/23
Company: Centocor Ortho Biotech
Asset: STELARA
Regulatory TimelineREG
Fast Track
Breakthrough
Priority Review
PDUFA
Approval
Company
Centocor Ortho Biotech
Signal assessment
Signal strength
high
Confidence level
moderate
Signalhigh
Confidencemoderate
Why it matters
The FDA's acceptance of a supplemental application for STELARA is significant as it may lead to an enhanced label and improved competitive positioning in the immunology market. Portfolio teams should prepare for potential new indications that could impact market strategies.
Recommended action
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Analysis
Monitor the FDA's review timeline and any announcements regarding approval outcomes.
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