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Humira News

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 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 ...

Humira (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis

NORTH CHICAGO, Ill., Feb. 24, 2021 /PRNewswire/ – AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved Humira (adalimumab) for the treatment of moderately to...

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 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 Hadlima (adalimumab-bwwd), a Biosimilar to Humira

INCHEON, Korea – July 24, 2019 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Hadlima (adalimumab-bwwd), a biosimilar referencing Humira (ad...

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...

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...

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...

AbbVie's Humira (adalimumab) Receives FDA Approval to Treat Adults with Non-Infectious Intermediate, Posterior and Panuveitis

NORTH CHICAGO, Ill., June 30, 2016 /PRNewswire/ – AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Humira...

FDA Approves Humira (adalimumab) for Moderate to Severe Hidradenitis Suppurativa

NORTH CHICAGO, Ill., Sept. 10, 2015 /PRNewswire/ – AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Humira...

FDA Approves Humira (adalimumab) for the Treatment of Pediatric Patients with Crohn's Disease

NORTH CHICAGO, Ill., Sept. 25, 2014 /PRNewswire/ – AbbVie announced today that the U.S. Food and Drug Administration (FDA) has approved Humira (adalimumab) for reducing signs and symptoms, and...

FDA Approves Humira to Treat Ulcerative Colitis

September 28, 2012 – The U.S. Food and Drug Administration today expanded the approved use of Humira (adalimumab) to include treatment of moderate-to-severe ulcerative colitis in adults. Humira is...

FDA Medwatch Alert: Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults

  [UPDATED 11/04/2011]  Healthcare professionals should remain vigilant for cases of malignancy in patients treated with TNF blockers, and report such cases to MedWatch. The reports should include: p...

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Ankylosing Spondylitis, Crohn's Disease, Crohn's Disease - Acute, Crohn's Disease - Maintenance, Plaque Psoriasis, Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis

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