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Psoriatic Arthritis News (Page 2)
Simponi Aria (golimumab) Approved by the FDA for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older
HORSHAM, PA, September 30, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Simponi Aria (golimumab) for p...
Tremfya (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis
HORSHAM, PA, July 14, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for adult p...
FDA Approves Hulio (adalimumab-fkjp), a Biosimilar to Humira
HERTFORDSHIRE, England and PITTSBURGH and TOKYO, July 9, 2020 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the U.S. Food and Drug Admini...
FDA Approves Avsola (infliximab-axxq), a Biosimilar to Remicade
THOUSAND OAKS, Calif., Dec. 6, 2019 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Avsola (infliximab-axxq) for all approved...
FDA Approves Abrilada (adalimumab-afzb), a Biosimilar to Humira
November 18, 2019 - Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Abrilada™ (adalimumab-afzb), as a biosimilar to Humira® (a...
Pfizer Announces FDA Approval of Xeljanz (tofacitinib) and Xeljanz XR for the Treatment of Active Psoriatic Arthritis
December 14, 2017 - Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration (FDA) has approved Xeljanz 5 mg twice daily (BID) and Xeljanz XR (tofacitinib) extended...
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...
Lilly's Taltz (ixekizumab) Receives U.S. FDA Approval for the Treatment of Active Psoriatic Arthritis
INDIANAPOLIS, Dec. 1, 2017 /PRNewswire/ – Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz (ixekizumab) injection 80 mg/mL for...
FDA Approves Simponi Aria (golimumab) for the Treatment of Adults With Active Psoriatic Arthritis or Active Ankylosing Spondylitis
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 n...
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...
Bristol-Myers Squibb’s Orencia (abatacept) Receives FDA Approval for Treatment of Active Psoriatic Arthritis in Adults
PRINCETON, N.J.--(BUSINESS WIRE) July 6, 2017 --Bristol-Myers Squibb Company (NYSE:BMY) announced today the U.S. Food and Drug Administration (FDA) has approved Orencia for the treatment of adults...
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 Erelzi (etanercept-szzs), a Biosimilar to Enbrel
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...
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...
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