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Psoriatic Arthritis News (Page 2)
FDA Approves Wezlana (ustekinumab-auub), an Interchangeable Biosimilar to Stelara
October 31, 2023 – Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory...
FDA Grants Interchangeable Designation to Pfizer’s Biosimilar Abrilada
NEW YORK, October 5, 2023 – Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has designated Abrilada™ (adalimumab-afzb) as an interchangeable biosimilar to Hum...
FDA Approves Novartis Cosentyx as First Intravenous (IV) Formulation Interleukin-17A Antagonist for Rheumatic Diseases
EAST HANOVER, N.J., Oct. 6, 2023 /PRNewswire/ – Novartis, a global leader in immuno-dermatology and rheumatology, announced today that the US Food and Drug Administration (FDA) has approved an...
FDA Approves Yuflyma (adalimumab-aaty), a Biosimilar to Humira
JERSEY CITY, N.J.--(BUSINESS WIRE) May 24, 2023 --Celltrion USA today announced that the U.S. Food and Drug Administration (FDA) has approved Yuflyma® (adalimumab-aaty), a high-concentration ...
Stelara (ustekinumab) Approved by the U.S. Food and Drug Administration to Treat Pediatric Patients with Active Psoriatic Arthritis
As the first and only biologic targeting both cytokines interleukin (IL)-12 and IL-23, Stelara provides a new therapeutic option for children six years of age and older living with active psoriatic...
Novartis Cosentyx Receives FDA Approval for the Treatment of Children and Adolescents with Enthesitis-Related Arthritis and Psoriatic Arthritis
- New approvals are based on JUNIPERA trial data showing Cosentyx® (secukinumab) demonstrated reduced flare risk versus placebo and improvement in disease activity observed over two years across ...
FDA Approves Yusimry (adalimumab-aqvh), a Biosimilar to Humira
REDWOOD CITY, Calif., Dec. 20, 2021 (GLOBE NEWSWIRE) – Coherus BioSciences, Inc. (Nasdaq: “CHRS”, “the Company”, “Coherus”) announced that the United States Food and Drug Administration (“FDA”) appro...
Rinvoq (upadacitinib) Receives U.S. FDA Approval for Active Psoriatic Arthritis
NORTH CHICAGO, Ill., Dec. 14, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Rinvoq® (upadacitinib; 15 mg, once daily) for the t...
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...
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