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Ankylosing Spondylitis News

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 ...

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 ...

FDA Approves Simponi Aria (golimumab) for the Treatment of Adults With Active Psoriatic Arthritis or Active Ankylosing Spondylitis

Posted 26 Oct 2017 by Drugs.com

Horsham, Pa., October 20, 2017 ― Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved Simponi Aria (golimumab), the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion, for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). Today’s approvals follow the ...

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 ...

2 of 3 Americans Don't Have 'Advance Directive' for End of Life

Posted 7 Jul 2017 by Drugs.com

FRIDAY, July 7, 2017 – Most people don't like talking about dying, especially their own death. But it's important to let your loved ones know how you'd like your medical care handled when your "time" comes. Yet, new research found that two-thirds of American adults haven't completed an advance directive. That's a legal document that outlines a person's wishes if they become incapacitated and ...

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 ...

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); ...

FDA Approves Erelzi (etanercept-szzs), a Biosimilar to Enbrel

Posted 1 Sep 2016 by Drugs.com

August 30, 2016 – The U.S. Food and Drug Administration today approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998. Erelzi is administered by injection for the treatment of: moderate to severe rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate (MTX); ...

Inflectra Approved as 'Biosimilar' to Remicade

Posted 7 Apr 2016 by Drugs.com

WEDNESDAY, April 6, 2016 – The U.S. Food and Drug Administration has approved its second-ever "biosimilar" drug, Inflectra, for adults with Crohn's disease, rheumatoid arthritis or chronic plaque psoriasis, among other prescribed uses. In a media release, the agency said Inflectra was biosimilar to Janssen Biotech's Remicade (infliximab), first licensed in 1998. A biosimilar drug is sanctioned ...

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

Posted 7 Apr 2016 by Drugs.com

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 biosimilar approved by the FDA. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. Inflectra is approved and can be prescribed by a health c ...

Novartis Receives FDA Approval for Cosentyx (secukinumab) to Treat Patients with Ankylosing Spondylitis and Psoriatic Arthritis

Posted 17 Jan 2016 by Drugs.com

EAST HANOVER, N.J., Jan. 15, 2016 Novartis announced today that the US Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for two new indications - the treatment of adult patients with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). AS and PsA are both life-long, painful and debilitating inflammatory diseases that affect the joints and/or spine. If ...

New Drug for Severe Form of Arthritis Shows Promise in Trial

Posted 24 Dec 2015 by Drugs.com

WEDNESDAY, Dec. 23, 2015 – A drug recently approved for the skin condition psoriasis may also help people with a debilitating form of arthritis that attacks the spine, a new clinical trial finds. The condition, called ankylosing spondylitis, causes inflammation around the vertebrae, which can lead to chronic pain and stiffness in the back and neck – and, in some people, eventually cause some ...

Cimzia Approved by FDA for Treatment of Adults with Active Ankylosing Spondylitis

Posted 23 Oct 2013 by Drugs.com

ATLANTA, Oct. 18, 2013 /PRNewswire/ – regulated information – UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Cimzia® (certolizumab pegol) for the treatment of adults with active ankylosing spondylitis (AS). The FDA also issued a Complete Response Letter relating to the supplemental Biologics License Application (sBLA) of Cimzia® for the treatment of adults wit ...

Horizon Pharma Announces FDA Approval of Rayos (prednisone) Delayed-Release Tablets for Rheumatoid Arthritis and Multiple Additional Indications

Posted 31 Jul 2012 by Drugs.com

DEERFIELD, Ill., July 26, 2012 /PRNewswire/ – Horizon Pharma, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Rayos (prednisone) delayed-release tablets (1 mg, 2 mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive ...

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prednisone, aspirin, naproxen, Celebrex, diclofenac, Humira, Aleve, Voltaren, Enbrel, view more... Remicade, cortisone, triamcinolone, indomethacin, dexamethasone, Arthritis Pain, Simponi, Vimovo, Cimzia, Bayer Aspirin, Cosentyx, sulindac, Decadron, Naprosyn, Naprelan, celecoxib, Ecotrin, Indocin, infliximab, adalimumab, Anaprox, Arthritis Pain Formula, Cataflam, Kenalog-40, Bufferin, etanercept, Midol Extended Relief, Deltasone, Inflectra, esomeprazole / naproxen, Cyltezo, Buffered Aspirin, Renflexis, Sterapred DS, Anaprox-DS, Ixifi, Rayos, Erelzi, Aspergum, Simponi Aria, Sterapred, Amjevita, Clinacort, Aspirin Buffered, Magnaprin, Voltaren-XR, Medidex, Liquid Pred, Meticorten, Cortone Acetate, Acthar Gel, HP, Acthar, Prednicot, Medidex LA, Dexpak Taperpak, Aspir-Mox, Orasone, Prednicen-M, ZoDex, Aspir-Mox IB, Dalalone DP, Flanax Pain Reliever, Zema Pak, Ecpirin, Zonacort, Decaject LA, Primethasone, Decaject, Dalalone LA, Dalalone, Prevacid NapraPAC 500, Aspirtab, LoCort, Baycadron, Adrenocot LA, Dexamethasone Intensol, Fasprin, Acth, Prevacid NapraPAC 375, Dexacorten, Ascriptin Enteric, Dexone LA, EC-Naprosyn, Buffex, Bayer Plus, Empirin, Halfprin, Sloprin, Easprin, Aflaxen, Naproxen Sodium DS, Indocin IV, Buffasal, Medi-Seltzer, Clinoril, Entercote, Dipentum, Prevacid NapraPAC, Indocin SR, Aspiritab, ZORprin, secukinumab, golimumab, certolizumab, olsalazine, lansoprazole / naproxen, corticotropin, Ecotrin Maximum Strength, Extra Strength Bayer, Dexone, YSP Aspirin, Dexasone LA, Dexasone, Dexacort-LA, De-Sone LA, Adrenocot, Solurex, Dexacen-4, Solurex LA, Decadron-LA, Hexadrol, Aspirin Lite Coat, Zero-Order Release, Genacote, Acetylsalicylic Acid, Norwich Aspirin, aluminum hydroxide / aspirin / calcium carbonate / magnesium hydroxide, Stanback Analgesic, Therapy Bayer, Bufferin Extra Strength, Entaprin, Tri-Buffered Aspirin, Minitabs, Litecoat Aspirin, Genprin, Gennin-FC, Hyrimoz