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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Updated: Feb 10, 2026

Labeling Stem Cells with Ferumoxytol, an FDA-Approved Iron Oxide Nanoparticle
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Tildrakizumab: First Global Approval.

Anthony Markham1

  • 1Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. dru@adis.com.

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This summary is machine-generated.

Tildrakizumab is a new treatment for moderate-to-severe plaque psoriasis. This interleukin-23 inhibitor has received US FDA approval following successful Phase III trials.

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Area of Science:

  • Immunology
  • Dermatology
  • Pharmacology

Background:

  • Chronic plaque psoriasis is a significant autoimmune condition.
  • Current treatments aim to manage symptoms and immune responses.
  • Interleukin-23 (IL-23) is a key cytokine implicated in psoriasis pathogenesis.

Purpose of the Study:

  • To summarize the development of tildrakizumab, a novel biologic agent.
  • To highlight the regulatory milestones leading to its approval.
  • To provide an overview of its efficacy in treating chronic plaque psoriasis.

Main Methods:

  • Development of tildrakizumab, a humanized monoclonal antibody targeting IL-23 p19.
  • Evaluation through the Phase III reSURFACE clinical trial program.
  • Assessment of safety and efficacy in adult patients with moderate-to-severe psoriasis.

Main Results:

  • Tildrakizumab demonstrated positive results in Phase III trials.
  • The drug targets the p19 subunit of interleukin-23.
  • Achieved US FDA marketing approval for plaque psoriasis treatment.

Conclusions:

  • Tildrakizumab offers a new therapeutic option for chronic plaque psoriasis.
  • The drug's targeted mechanism addresses a key inflammatory pathway.
  • FDA approval signifies clinical effectiveness and safety for eligible adult patients.