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Ankylosing Spondylitis News
UCB announces U.S. FDA approvals for Bimzelx (bimekizumab-bkzx) for the treatment of psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis
Brussels (Belgium), September 23, 2024 – 07:00 (CEST) – UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Bimzelx (bi...
FDA Approves Bimzelx for Three New Indications
THURSDAY, Sept. 26, 2024 – The U.S. Food and Drug Administration has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active n...
FDA Approves Simlandi (adalimumab-ryvk), an Interchangeable Biosimilar to Humira
REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) – Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE:...
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 ...
Rinvoq (upadacitinib) Approved by U.S. FDA as an Oral Treatment for Adults with Active Ankylosing Spondylitis
Across the two pivotal trials, Rinvoq delivered rapid and meaningful disease control with nearly half of ankylosing spondylitis (AS) patients achieving ASAS40 (51% and 44.5% with Rinvoq versus 26% ...
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...
U.S. FDA Approves Pfizer’s Xeljanz (tofacitinib) for the Treatment of Active Ankylosing Spondylitis
NEW YORK--(BUSINESS WIRE) December 14, 2021 – Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for...
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...
FDA Approves Taltz (ixekizumab) for the Treatment of Active Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)
INDIANAPOLIS, Aug. 26, 2019 /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 Eticovo (etanercept-ykro), a Biosimilar to Enbrel
INCHEON, Korea – As of April 2019 – Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved Eticovo (etanercept-ykro), a biosimilar referencing Enbrel (et...
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...
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