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Adalimumab News
US FDA Approves High-Concentration, Citrate-Free Formulation of Cyltezo (adalimumab-adbm) injection
RIDGEFIELD, Conn., May 1, 2024 /PRNewswire/ – Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of ...
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:...
Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products
October 26, 2023 – Over the last eight years, FDA has approved more than 40 biosimilar products (biosimilars), and they have become an important treatment option for health care professionals and...
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...
Treatment Effect of Tofacitinib, Adalimumab Compared in RA
WEDNESDAY, July 12, 2023 – For adults with rheumatoid arthritis (RA), there is a modest reduction in the mean Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) at three months...
Monthly News Roundup - May 2023
FDA Approves Once-Daily SGLT Inhibitor Inpefa to Treat Heart Failure Over 6 million Americans suffer from heart failure, with the prevalence expected to rise to 8 million by 2030. In response, the US...
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 ...
US FDA Approves the Cyltezo Pen, a New Autoinjector Option, Ahead of July 1 Commercial Launch
RIDGEFIELD, Conn., May 22, 2023 /PRNewswire/ -- Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the Cyltezo® Pen, a new autoinjector option for ...
Sandoz Receives US FDA Approval for Biosimilar Hyrimoz (adalimumab-adaz) High-Concentration Formulation
Biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation (HCF) approved for seven indications of reference medicine Humira®* With this approval, Sandoz adalimumab HCF biosimilar will o...
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...
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 Cyltezo (adalimumab-adbm) as First Interchangeable Biosimilar to Humira
Regulatory approval for Interchangeability was supported by positive data from Boehringer Ingelheim’s Phase III randomized VOLTAIRE-X clinical trial Data showed that switching several times b...
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...
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