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  1. U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO ...

    − ENTYVIO is Now Available in the U.S. in Both IV and Subcutaneous Administrations for Maintenance Treatment of Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease Takeda …

  2. ENTYVIO Is the Only FDA-Approved Ulcerative Colitis Biologic That Offers the Choice of Intravenous or Subcutaneous Maintenance Therapy C is expected to be available in the U.S. as a single-dose pre …

  3. ENTYVIO® (vedolizumab) Frequently Asked Questions

    Is the ENTYVIO Pen available to patients? Yes, the ENTYVIO Pen is approved by the FDA for maintenance therapy to adults with moderate to severe ulcerative colitis or Crohn’s disease after at …

  4. ENTYVIO® (vedolizumab) Dosing and Administration

    ENTYVIO® dosing and administration for IV infusion and subcutaneous injection. Find infusion schedule, storage, and injection site information.

  5. FDA Approves Subcutaneous Administration of ENTYVIO - Takeda

    Apr 18, 2024 · ENTYVIO is Now Available in the U.S. in Both IV and Subcutaneous Administrations for Maintenance Treatment of Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s …

  6. FDA approves subcutaneous administration of Entyvio (vedolizumab) …

    Apr 29, 2024 · The approval is based on the VISIBLE 2 Study (SC CD Trial), a Phase III, randomized, double-blind, placebo-controlled trial, which assessed the safety and efficacy of an SC formulation of …

  7. Vedolizumab (Entyvio) SC Approved for Maintenance Therapy in …

    Apr 22, 2024 · The approval of vedolizumab SC was based on the phase 3 randomized, double-blind placebo-controlled VISIBLE 2 trial, which enrolled 409 adults with moderately to severely active …

  8. *If TB results are positive - please provide documentation of treatment or medical clearance, and a negative CXR nce company for eligibility. Our team will notify you if an additi nal information is …

  9. U.S. FDA Approves Subcutaneous Administration of Takeda's ENTYVIO

    Sep 27, 2023 · U.S. FDA Approves Subcutaneous Administration of Takeda's ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis

  10. FDA approves Takeda’s ENTYVIO for maintenance therapy in active …

    Apr 21, 2024 · ENTYVIO was also approved by FDA in September 2023 for the maintenance treatment of adults with moderately to severely active ulcerative colitis and is available in the U.S. as a single …