Janssen Biotech, Inc.
Malvern, PA
Works in Dermatology · GI & liver · Hematology · Immunology · Musculoskeletal · Oncology · Renal & urogenital
Janssen Biotech, Inc. is a clinical trial sponsor based in Malvern, PA. It has 2 active clinical trials with 5,505 planned participants, across 7 therapeutic areas. Since 2021 it has completed 4 trials and stopped 0 early. Its FDA record on file shows 1 recall.
Trial track record · since 2021
FDA record
Recent FDA actions
Pipeline · 2 active trials
| Stage | Trial | Status |
|---|---|---|
On the market
18 approved drug applications with a product on the market.
Questions about Janssen Biotech, Inc
No warning letter naming Janssen Biotech, Inc is on file. FDA has published 1 recall naming it.
Yes. FDA's enforcement reports list 1 recall by Janssen Biotech, Inc; the latest, reported on 2026-10-14, is a Class II recall.
Janssen Biotech, Inc is lead sponsor of 2 active clinical trials on ClinicalTrials.gov, with 5,505 planned participants, in Dermatology, GI & liver, Hematology, Immunology and other areas. Since 2021 it has completed 4 trials and stopped 0 early.
Janssen Biotech, Inc is based in Malvern, PA. The address is the one on its FDA records or ClinicalTrials.gov registrations, which name the establishment or the registrant, not always the group's head office.
From public sources only: ClinicalTrials.gov for trials, FDA's Data Dashboard, warning-letter listing and enforcement reports for the FDA record, and SEC filings for financials. Approve Suite is not affiliated with Janssen Biotech, Inc; every record links to the source, and nothing here is advice.
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Trial counts are as the sponsor reported them to ClinicalTrials.gov, for trials changed since 2021; latest update 2026-09-25.
The FDA record counts inspection classifications, warning letters and recalls FDA has published that name this company. Compare it with the industry in the free CDMO FDA inspection lookup.
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