HeyJaredAllegra J. Padula
- Indexed articles, last 90 days
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- Aug 31, 2026
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- Aug 31, 2026
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Biocon Announces Supplemental U.S. FDA Approval For Prefilled Autoinjector For YESINTEK (opens the original)
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On August 18, 2026, Biocon Ltd. (“Biocon”) announced that its U.S. subsidiary has received supplemental U.S. FDA approval for YESINTEK® (ustekinumab-kfce) in a single-dose prefilled autoinjector, 45 mg/0.5 mL and 90 mg/mL. YESINTEK® was originally approved by the FDA on November 29, 2024, in 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe; 45 mg/0.5 mL solution in a single-dose vial; and 130 mg/26 mL solution in a single-dose vial. YESINTEK®, biosimilar to Janssen Biotech’s
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