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active ulcerative colitis
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Janssen Biotech Has Announced The FDA Approval of Simponi (Golimumab) to Treat Moderately
May 17, 2013Janssen 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
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Takeda Pharmaceutical Company Has Submitted MAA Seeking Approval From The EMA
Mar 11, 2013Takeda Pharmaceutical Company has submitted marketing authorisation application (MAA) seeking approval from the European Medicines Agency (EMA) for its investigational, gut-selective humanized monoclonal antibody for the treatment of adults ...
Tags: Takeda, IBD Disease Drug, MAA, EMA
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The US FDA Has Approved Warner Chilcott's 400mg Mesalamine Product
Feb 13, 2013The US FDA has approved Warner Chilcott's 400mg mesalamine product as new ulcerative colitis therapy, to be marketed as Delzicol. Warner expects to commercially launch Delzicol in March 2013. Delzicol delayed-release capsules are ...
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The Drug Is Used to Treat Adult Patients with Moderately to Severely Active UC
Dec 5, 2012Janssen 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
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A New Drug (IND) Application Clearance for The Treatment of Ulcerative Colitis
Nov 29, 2012Biotechnology 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
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