The US FDA has approved Janssen Biotech's Simponi ARIA (golimumab) for infusion to treat moderately to severely active rheumatoid arthritis (RA). Simponi ARIA is the only fully-human anti-tumor necrosis factor (TNF)-alpha infusible ...
Janssen Biotech has announced the FDA approval of Simponi (golimumab) to treat moderately to severely active ulcerative colitis (UC) in adult patients with corticosteroid dependence or an inadequate response to or failed to tolerate oral ...
Tags: FDA, Janssen Biotech
Janssen Biotech and Janssen Biologics have submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) seeking approval of Simponi ...
Tags: Simponi, golimumab, active ulcerative colitis, anti-tumor necrosis factor
Biotechnology company Avaxia Biologics has received AVX-470 investigational new drug (IND) application clearance for the treatment of ulcerative colitis from the FDA. The bovine anti-tumor necrosis factor polyclonal antibody is based on ...
Tags: Avaxia, Ulcerative Colitis Therapy, IND