SPRING HOUSE, PA – Johnson & Johnson (NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for a subcutaneous ...
The request is based on findings from the Phase III ASTRO study, which achieved the primary endpoint of clinical remission at ...
If approved, JNJ's Tremfya will be the first IL-23 inhibitor to offer a choice of subcutaneous or intravenous use as ...
The new ulcerative colitis (UC) triumvirate in Johnson & Johnson’s Tremfya, AbbVie’s Skyrizi and Eli Lilly’s Omvoh is rapidly ...
Johnson & Johnson (JNJ) announced the submission of a supplemental Biologics License Application to the FDA seeking approval of a ...
Johnson & Johnson announced the submission of a supplemental Biologics License Application to the U.S. FDA seeking approval of a ...
The FDA approved Tremfya in September 2024 for moderately to severely active ulcerative colitis. The application for moderately to severely active Crohn's disease is currently under FDA review.
Tremfya (guselkumab) is a prescription drug that’s used to treat certain autoimmune conditions, including plaque psoriasis. Tremfya can cause side effects that range from mild to serious.