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Ulcerative Colitis News (Page 4)

Related terms: Colitis, Ulcerative, UC, Colitis Ulcerosa

FDA Medwatch Alert: FDA Approves Boxed Warning About Increased Risk of Blood Clots and Death with Higher Dose of Tofacitinib (Xeljanz, Xeljanz XR)

July 26, 2019 – The U.S. Food and Drug Administration has approved new warnings about an increased risk of blood clots and of death with the 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz...

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

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...

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

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,...

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

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...

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

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 p...

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

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 Rem...

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

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...

FDA Approves Inflectra (infliximab-dyyb) a Biosimilar to Remicade

April 5, 2016 – The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second...

FDA Approves Uceris (budesonide) Rectal Foam for Ulcerative Colitis

RALEIGH, N.C., October 8, 2014 – Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Food and Drug Administration (FDA) has granted final approval for Uceris (budesonide) rectal foam...

FDA Approves Entyvio (vedolizumab) to treat Ulcerative Colitis and Crohn's Disease

May 20, 2014 – The U.S. Food and Drug Administration today approved Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with...

FDA Approves Simponi to Treat Ulcerative Colitis

May 15, 2013 – The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis. Simponi works by blocking...

Warner Chilcott Announces FDA Approval of New Ulcerative Colitis Product Delzicol

DUBLIN, Ireland, Feb. 5, 2013 – Warner Chilcott plc today announced that the United States Food and Drug Administration (FDA) has approved its new 400 mg mesalamine product indicated for the...

Santarus Receives FDA Approval of Uceris (budesonide) for the Induction of Remission in Patients with Active, Mild to Moderate Ulcerative Colitis

SAN DIEGO--(BUSINESS WIRE)--Jan 15, 2013 - Santarus, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Uceris (budesonide) extended release tablets for the induction...

FDA Approves Humira to Treat Ulcerative Colitis

September 28, 2012 – The U.S. Food and Drug Administration today expanded the approved use of Humira (adalimumab) to include treatment of moderate-to-severe ulcerative colitis in adults. Humira is...

FDA Approves Remicade to Treat Ulcerative Colitis in Children Older than 6 Years

The U.S. Food and Drug Administration today approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children older than 6 years who have had inadequate...

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Further information

Related condition support groups

Ulcerative Colitis - Active, Colitis

Related drug support groups

Humira, clonidine, hydrocortisone, Stelara, Entyvio, Remicade, Xeljanz, Skyrizi, dexamethasone, adalimumab, budesonide, ustekinumab