Monthly Prescribing Reference

Fatigue Assessment Included in Simponi Aria Labeling

The prescribing information for the product has been updated to include this health related outcome. The Food and Drug Administration (FDA) has approved new labeling for Simponi Aria® (golimumab ...
WebMD

FDA Expands Approval of Simponi for Use in Pediatric Patients with Ulcerative Colitis

What Is Simponi, and Why Does It Matter? The FDA has approved Simponi (golimumab) for children with moderately to severely active ulcerative colitis (UC) who weigh at least 15 kilograms (33 pounds).
Monthly Prescribing Reference

Simponi Approved for Ulcerative Colitis

SIMPONI (Golimumab) 50mg/0.5mL solution for SC inj from Centocor Ortho Biotech The FDA has approved Simponi (golimumab for subcutaneous injection; Janssen Biotech) to induce and maintain clinical ...
FiercePharma

SIMPONI® (golimumab) Gains Positive Opinion from Committee for Medicinal Products for Human Use (CHMP) for the Treatment of Non-Radiographic Axial Spondyloarthritis

The CHMP positive opinion was based on the findings from the GO-AHEAD study, which demonstrated significant clinical improvement in patients with active nr-axial SpA treated with golimumab, compared ...
BioWorld

Xian Janssen launches Simponi, expands anti-TNF options for patients in China

HONG KONG – Xian Janssen Pharmaceutical Ltd. has launched Simponi (golimumab injection), making it the first once-monthly self-injectable anti-TNF biologic for patients with active ankylosing ...
FiercePharma

Centocor Ortho Biotech Inc. Submits Application to FDA Seeking to Expand SIMPONI® Label in Treatment of Rheumatoid Arthritis

HORSHAM, Pa., Sept. 27 /PRNewswire/ -- Centocor Ortho Biotech Inc. announced today that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration ...