FDA

January 22, 2020January 22, 2020

Phase 2 Trial of Oral Treatment for Ulcerative Colitis Expanding to US, Abivax Says

News

The U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for ABX464, Abivax’s treatment candidate for ulcerative colitis (UC), allowing the company to expand its Phase ... Read more

October 22, 2019October 22, 2019

Stelara Approved in US to Treat Moderate-to-Severe Ulcerative Colitis

News

The U.S. Food and Drug Administration (FDA) has approved Stelara (ustekinumab) for the treatment of adults with ulcerative colitis (UC) that is moderately to severely active, Janssen Pharmaceuticals, Stelara’s developer and ... Read more

June 1, 2018June 1, 2018

FDA Approves Pfizer’s Xeljanz, an Oral Twice Daily Treatment for Adults with Moderate to Severe Ulcerative Colitis

News

The U.S. Food and Drug Administration (FDA) has approved the oral therapy Xeljanz (tofacitinib), by Pfizer, to treat adults with moderately to severely active ulcerative colitis (UC), the company announced. The treatment regimen calls ... Read more

March 28, 2018March 28, 2018

FDA Approves Cimzia Label Update Essential for Childbearing Women with Inflammatory Diseases

News

The U.S. Food and Drug Administration (FDA) recently approved UCB’s request for a label update for Cimzia (certolizumab pegol) indicating low transfer levels of the medication from mother to child through ... Read more

March 12, 2018March 12, 2018

FDA Advisory Panel Favors Extended Use of Xeljanz by Certain Ulcerative Colitis Patients

News

An advisory arm of the U.S. Food and Drug Administration (FDA) gave two positive recommendations to Pfizer’s supplemental New Drug Application, seeking FDA approval for extended use of Xeljanz (tofacitinib) by certain adult ... Read more

January 19, 2018January 19, 2018

Vitality Biopharma Seeks FDA’s Orphan Drug Status for Cannabinoid Therapy VITA-100

News

Vitality Biopharma is seeking orphan drug designation from the U.S. Food and Drug Administration (FDA) for its targeted cannabinoid therapy, VITA-100, for the treatment of pediatric ulcerative colitis. The FDA grants orphan ... Read more

January 17, 2018

FDA to Review Sandoz’s Application for Biosimilar to Bowel Disease Therapy Humira

News

The U.S. Food and Drug Administration has agreed to review Sandoz’s application for a biosimilar to AbbVie’s bowel disease therapy Humira (adalimumab). “When patients are dealing with a chronic disease, it is imperative ... Read more

January 15, 2018

FDA OKs Application for Immunic’s UC Therapy, Green-lighting Phase 2 Trial

News

The U.S. Food and Drug Administration has cleared the way for Immunic Therapeutics to begin a Phase 2 trial testing IMU-838, its therapy candidate for ulcerative colitis. The FDA’s approval of Immunic’s investigational new drug ... Read more

January 5, 2018

Palatin to Start Clinical Trials of Ulcerative Colitis Therapy After FDA Sign-off

News

Palatin Technologies plans to start clinical trials of its ulcerative colitis therapy PL-8177 in the next three months. The U.S. Food and Drug Administration’s decision to accept Palatin’s Investigational New Drug application for the treatment opened ... Read more

October 24, 2017October 24, 2017

TiGenix Potential Therapy for Crohn’s-related Perianal Fistulas Gets FDA Approval

News

The U.S. Food and Drug Administration (FDA) has granted TiGenix orphan drug designation for its lead candidate Cx601, which aims to treat perianal fistulas caused by Crohn’s disease in patients who have ... Read more