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Juvenile Idiopathic Arthritis News
FDA Approves Avtozma (tocilizumab-anoh), a Biosimilar to Actemra
JERSEY CITY, N.J., Jan. 30, 2025 – Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved Avtozma® (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and ...
FDA Approves Tyenne (tocilizumab-aazg), a Biosimilar to Actemra
March 7, 2024 – Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic...
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 Tofidence (tocilizumab-bavi), a Biosimilar to Actemra
CAMBRIDGE, Mass., Sept. 29, 2023 (GLOBE NEWSWIRE) – Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) intravenous...
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 ...
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...
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...
U.S. FDA Approves Pfizer’s Xeljanz (tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis
NEW YORK--(BUSINESS WIRE) September 28, 2020 – Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib) for the ...
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 RediTrex (methotrexate) for Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, and Psoriasis
NASHVILLE, Tenn., Dec. 2, 2019 /PRNewswire/ – Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, today announced that it has received approval from the U.S. Food and...
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 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...