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Related terms: Colitis, Ulcerative

FDA Approves Hyrimoz (adalimumab-adaz), a Biosimilar to Humira

Posted 1 Nov 2018 by Drugs.com

Holzkirchen, Germany, October 31, 2018 - Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar, Hyrimoz (adalimumab-adaz). The FDA granted approval for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) in patients four years of age and older, psoriatic ...

Pfizer Announces U.S. FDA Approves Xeljanz (tofacitinib) for the Treatment of Moderately to Severely Active Ulcerative Colitis

Posted 1 Jun 2018 by Drugs.com

Wednesday, May 30, 2018 - Pfizer Inc. announced today that the United States (U.S.) Food and Drug Administration (FDA) approved Xeljanz (tofacitinib) 10 mg twice-daily (BID) for at least eight weeks, followed by Xeljanz 5 mg BID or 10 mg BID, for the treatment of adult patients in the U.S. with moderately to severely active ulcerative colitis (UC).1 “Ulcerative colitis is a chronic inflammatory b ...

Xeljanz (Tofacitinib) Approved for Ulcerative Colitis

Posted 30 May 2018 by Drugs.com

WEDNESDAY, May 30, 2018 – U.S. Food and Drug Administration approval of Xeljanz (tofacitinib) has been expanded to include adults with active moderate-to-severe ulcerative colitis, the agency said Wednesday. Ulcerative colitis (UC) is a chronic inflammatory bowel disease, characterized by recurring flares of abdominal pain and bloody diarrhea. Symptoms also may include fatigue, weight loss and ...

FDA Approves Ixifi (infliximab-qbtx), a Biosimilar to Remicade

Posted 14 Dec 2017 by Drugs.com

December 13, 2017 – Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Ixifi (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab)* for all eligible indications of the reference product.1 The FDA has approved Ixifi as a ...

Inflammatory Bowel Disease May Raise Cancer Risk in Kids

Posted 21 Sep 2017 by Drugs.com

THURSDAY, Sept. 21, 2017 – Children with inflammatory bowel disease (IBD) face an increased risk of cancer, a new study claims. The risk persists into adulthood, and is especially elevated for gastrointestinal cancers, the researchers added. The "extent and duration of chronic inflammation might be the main driving mechanisms underlying the increased risk of cancer," the researchers suggested. ...

FDA Approves Cyltezo (adalimumab-adbm), a Biosimilar to Humira

Posted 30 Aug 2017 by Drugs.com

Ridgefield, Conn., August 29, 2017 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Cyltezo, a biosimilar to Humira, in a pre-filled syringe for the treatment of multiple chronic inflammatory diseases, including: moderate to severe active rheumatoid arthritis moderate to severe polyarticular juvenile idiopathic arthritis** a ...

Scientists Spot Genes Behind Crohn's, Ulcerative Colitis

Posted 29 Jun 2017 by Drugs.com

THURSDAY, June 29, 2017 – Researchers say they've come closer to pinpointing genes linked with inflammatory bowel diseases such as Crohn's and ulcerative colitis. For the study, the investigators examined the genomes of nearly 68,000 people. Of the regions of the genome associated with inflammatory bowel disease (IBD), 18 could be traced to a single genetic variant with more than 95 percent ...

Arthritis Drug Shows Promise for Ulcerative Colitis

Posted 4 May 2017 by Drugs.com

WEDNESDAY, May 3, 2017 – A new study finds that people with moderate to severe ulcerative colitis who haven't done well on other treatments may find relief with Xeljanz (tofacitinib), a drug currently used to treat arthritis. Ulcerative colitis is a chronic inflammatory bowel disease. It affects about 700,000 Americans, according to the Crohn's and Colitis Foundation (CCF). The illness causes ...

FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade

Posted 27 Apr 2017 by Drugs.com

INCHEON, Korea – April 24, 2017 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Renflexis (infliximab-abda), a biosimilar referencing Remicade®i (infliximab), across all eligible indications. In the US, Renflexis is indicated for reducing signs and symptoms in patients with adult and pediatric Crohn’s disease, adult ulcerative colitis, rheu ...

New Meds Make Inroads Against Crohn's Disease

Posted 13 Apr 2017 by Drugs.com

THURSDAY, April 13, 2017 – Fewer Americans with Crohn's disease are ending up in the hospital than in the past, according to a new federal study. Crohn's is a chronic inflammatory bowel disorder that often leads to surgery for most with the disease. Hospitalization rates for Crohn's disease remained stable in the United States between 2003 and 2013. That's a change from a study done from 1998 to ...

Special Diet May Be Boon for Kids With Crohn's, Colitis

Posted 10 Jan 2017 by Drugs.com

MONDAY, Jan. 9, 2017 – Children with Crohn's disease and ulcerative colitis may be able to achieve relief without medications by eating a special diet, a small study suggests. The diet includes non-processed foods, such as fruits, vegetables, meats and nuts. Over 12 weeks, the diet appeared to ease all signs of these inflammatory bowel diseases in eight of the 10 affected children, researchers ...

Amjevita Approved to Treat Inflammatory Diseases

Posted 27 Sep 2016 by Drugs.com

MONDAY, Sept. 26, 2016 – Amjevita (adalimumab-atto) – a biosimilar drug similar to the popular anti-inflammatory drug Humira – has been approved by the U.S. Food and Drug Administration. Amjevita has been approved for moderate-to-severe rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis (an arthritis that affects the spine); Crohn's disease; ulcerative colitis; plaque psoriasis ...

FDA Approves Amjevita (adalimumab-atto), a Biosimilar to Humira

Posted 26 Sep 2016 by Drugs.com

September 23, 2016 – The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases. Amjevita is approved for the following indications in adult patients: moderately to severely active rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis (an arthritis that affects the spine); ...

Vitamin A Compound Might Aid in Colon Cancer Fight

Posted 30 Aug 2016 by Drugs.com

TUESDAY, Aug. 30, 2016 – Retinoic acid, a compound derived in the body from vitamin A, might have a role in suppressing colon cancer, new animal research suggests. "Retinoic acid has been known for years to be involved in suppressing inflammation in the intestine," said study senior author Dr. Edgar Engleman, professor of pathology and medicine at Stanford University School of Medicine in Palo ...

Stool Transplant Soothes Tough-to-Treat Colitis in Study

Posted 23 May 2016 by Drugs.com

MONDAY, May 23, 2016 – Stool transplants helped ease debilitating symptoms and heal the colons of tough-to-treat ulcerative colitis patients, new research shows. Australian scientists said the findings could pave the way for such transplants to be used on a more widespread basis. Transferring fecal matter from healthy donors into these patients alters the composition of their gut bacteria, ...

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