-
FDA Approves Johnson & Johnson’s Simponi for Pediatric Ulcerative Colitis
08 Oct 2025 22:55 GMT
… & Johnson Innovative Medicine. “The approval of Simponi represents a meaningful milestone … trials of Simponi in adults with UC.
Simponi is an anti-TNF biologic medicine … .1
U.S. FDA approves SIMPONI® (golimumab) for the treatment of pediatric ulcerative …
-
<![CDATA[FDA Approves Golimumab for Treatment of Pediatric Ulcerative Colitis]]>
09 Oct 2025 01:14 GMT
… Drug Administration (FDA) approved golimumab (Simponi; Johnson & Johnson) for the treatment … also consistent with clinical trials evaluating golimumab in adults. … Gasink, MD, vice president, medical affairs, gastroenterology & autoantibody, Johnson …
-
FDA approves golimumab for pediatric ulcerative colitis
09 Oct 2025 00:48 GMT
… Medicine, said in the release. “The approval of Simponi … where treatment options have historically been limited.”
The FDA based … two multicenter, open-label trials that evaluated the efficacy, … consistent with prior clinical trials of golimumab among adults …
-
FDA OKs Simponi for Pediatric Ulcerative Colitis
08 Oct 2025 17:36 GMT
The FDA approved the TNF-alpha inhibitor golimumab (Simponi, Johnson & … active UC.
In the trial, the primary endpoint of … were consistent with clinical trials of golimumab in adults … Full prescribing information and medication guide is available online.
-
FDA Expands Johnson & Johnson Ulcerative Colitis Drug Approval To Pediatric Patients
08 Oct 2025 17:07 GMT
… and Drug Administration (FDA) approved Johnson & Johnson’s (NYSE:JNJ) Simponi (golimumab … and pharmacokinetics of subcutaneously administered Simponi for pediatric ulcerative colitis.
In … 68 billion, operates in the pharmaceuticals sector, where it has …
-
J&J gets FDA4S green light for Simponi in children with ulcerative colitis
08 Oct 2025 16:03 GMT
… the US FDA of Simponi (golimumab) for the treatment of children … treatment already approved in adults and makes Simponi the only drug … Gasink, Vice President of Medical Affairs, says that this … new safe and effective treatment option for children for …
-
RINVOQ® Demonstrated Superiority Versus HUMIRA® for Primary Endpoint in a Head-to-Head Study in Rheumatoid Arthritis Patients Who Have Failed First TNF Inhibitor
20 Oct 2025 16:43 GMT
… treatment and their eczema is not well controlled with other pills … of prescription drugs to the FDA. Visit www.fda.gov… any vaccines
Also tell your doctor about all the medicines you … pegol), or SIMPONI® (golimumab). Tell your doctor if you have …
-
JnJ Simponi bags USFDA okay for pediatric ulcerative colitis
08 Oct 2025 07:21 GMT
… Food and Drug Administration (FDA) for SIMPONI (golimumab) for the treatment of children living … Gasink, M.D., Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson … are consistent with clinical trials of SIMPONI in adults with UC …
-
European Medicines Agency Recommends Marketing Approval of Gobivaz®, Alvotech’s Proposed Biosimilar to Simponi® (golimumab) with Advanz Pharma as Commercialization Partner
22 Sep 2025 08:30 GMT
… the reference biologic Simponi® is an important treatment option for … Alvotech
Alvotech is a biotech company, founded by Robert … disease medicines. Advanz Pharma is a global pharmaceutical company … satisfactory responses to the FDA’s inspection findings and …
-
Human medicines European public assessment report (EPAR): Gobivaz, golimumab, Status: Opinion
19 Sep 2025 10:30 GMT
… quality, safety and efficacy to Simponi.
The full indication is:
Rheumatoid … -inflammatory drugs (NSAIDs).
Ulcerative colitis (UC)
Gobivaz is indicated for treatment of … to or have medical contraindications for such therapies.
Treatment with Gobivaz is …