Alvotech Wins FDA Review Acceptance for AVT80 Biosimilar
Reykjavik, Iceland – August 31, 2026 Alvotech announced that the U.S. FDA has accepted for review its Biologics License...
Vedolizumab
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Fresenius Kabi’s Vedolizumab Biosimilar Accepted for FDA and EMA Review
BAD HOMBURG, Germany, July 31, 2026 Fresenius Kabi, an operating company of Fresenius, announced that both the U.S. Food...
Polpharma Biologics Secures FDA and EMA Review for PB016
ROTKREUZ, Switzerland, July 31, 2026 Polpharma Biologics International AG announced that the U.S. Food and Drug Administration (FDA) and...
Takeda’s ENTYVIO Nears Pediatric IBD FDA Approval
OSAKA, Japan and CAMBRIDGE, Massachusetts, June 9, 2026 Takeda has reached a significant regulatory milestone with the U.S. Food...
Alvotech Reports Positive PK Data for Entyvio Biosimilar
REYKJAVIK, Iceland, Feb. 5, 2026 —Alvotech announced positive top-line results from a pivotal pharmacokinetic (PK) study evaluating AVT80, its...
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