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Innovation Pharmaceuticals Doses First Cohort of Oral Brilacidin for Ulcerative Colitis americanpharmaceuticalreview
January 19, 2020
Innovation Pharmaceuticals has dosed the first cohort in its Phase 1 trial to investigate the use of delayed release tablets for colonic delivery of Brilacidin in healthy volunteers. This study formally launches the Company’s clinical program in Ulcerativ
Takeda submits NDA for SC formation of ulcerative colitis treatment pharmaceutical-technology
August 09, 2019
Takeda Pharmaceutical has submitted a new drug application (NDA) in Japan for a subcutaneous (SC) formulation of vedolizumab to treat adults with moderately to severely active ulcerative colitis (UC).
FDA adds boxed warning to Pfizer’s Xeljanz drug in ulcerative colitis pharmaceutical-technology
July 30, 2019
The US Food and Drug Administration (FDA) has approved boxed warning of higher blood clots and death risk with 10mg twice-daily dose of Pfizer’s Xeljanz (tofacitinib) drug in ulcerative colitis patients.
Takeda’s Entyvio bests AbbVie’s Humira in ulcerative colitis trial pharmatimes
March 12, 2019
In the Phase III VARSITY trial, Entyvio (vedolizumab) was found to be superior to Humira (adalimumab) in achieving statistically significant clinical remission at week 52 in patients with moderately to severely active ulcerative colitis.
Ustekinumab could be approved to treat ulcerative colitis europeanpharmaceuticalreview
January 09, 2019
Ustekinumab has been submitted to be the first interleukin (IL)-12/23 inhibitor licensed for the treatment of ulcerative colitis…
Janssen files Stelara in Europe for ulcerative colitis pharmatimes
January 08, 2019
Janssen has submitted a Group Type II Variation Application to the European Medicines Agency (EMA) seeking approval of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).
Janssen Submits Application to FDA for Stelara as Ulcerative Colitis Treatment americanpharmaceuticalreview
December 24, 2018
Janssen Pharmaceutical announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of.....
New Data Released on Stelara for Ulcerative Colitis americanpharmaceuticalreview
October 12, 2018
Janssen announced new data showing treatment with a single intravenous (IV) dose of Stelara (ustekinumab) induces clinical remission and response in adults with moderate to severe ulcerative colitis (UC) who previously experienced an inadequate response o
Pfizer receives EU nod for Ulcerative Colitis drug XELJANZ biospectrumasia
August 02, 2018
XELJANZ is the first and only oral therapy and Janus kinase (JAK) inhibitor to be approved for this patient population
Pfizer's Xeljanz cleared for ulcerative colitis in Europe pharmatimes
August 02, 2018
The European Commission has approved Pfizer’s Xeljanz (tofacitinib citrate) for ulcerative colitis (UC), making it the first oral therapy and Janus kinase (JAK) inhibitor to be approved for this patient population.

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