On November 2, 2025, the FDA issued a complete response letter (CRL) for Alvotech’s abbreviated Biologics License Application (aBLA) for its proposed Simponi ® (golimumab) biosimilar AVT05. The CRL ...
On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab ...
Please provide your email address to receive an email when new articles are posted on . The FDA has approved golimumab for the treatment of children with moderately to severely active ulcerative ...
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