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Leadiant Biosciences Inc.

Division of Sigma-Tau Finanziaria SPA
leadiant.com

Latest From Leadiant Biosciences Inc.

Leadiant Hit By Second Complaint Over Price Of CTX Drug In Europe

A second complaint has been filed, this time in Belgium, over the “excessive” price hike on Leadiant’s CDCA-containing drug for the rare genetic disorder, CTX.

Belgium Netherlands

Japan Approvals Include World-First For Skyrizi, Kymriah As Asia's First CAR-T

Japan approves a large batch of new products including significant first nods globally for AbbVie's antibody for psoriasis and Japan's first gene-based therapy, as well as a pioneering first approval in Asia for a CAR-T drug.

Japan Approvals

CDER's Novel Approvals In 2018 Show Remarkable Review Consistency

Years of regulatory fine-tuning culminated in record low average time to approval of 9.9 months for novel agents at US FDA’s drug center.
Drug Review Drug Approval Standards

US FDA Marches Toward Record Novel Approvals With Ionis’ Tegsedi, Leadiant’s Revcovi

Complete response letter for Acacia’s Barhemsys is only rain on Oct. 5 approval parade.

 

United States Approvals
See All

Company Information

  • Industry
  • Pharmaceuticals
    • OTC, Consumer
  • Therapeutic Areas
  • Cancer
  • Gastrointestinal
  • Gynecological, Urological
  • Immune Disorders
  • Infectious & Viral Diseases
  • Ophthalmic
  • Renal System
  • Alias(es)
  • Sigma-Tau Pharmaceuticals Inc.
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Sigma-Tau Finanziaria SPA
  • Senior Management
  • Michael Minarich, CEO
    Giuseppe Izzi, VP, Fin.
    Taha Keilani, MD, VP, CMO
  • Contact Info
  • Leadiant Biosciences Inc.
    Phone: (301) 948-1041
    9841 Washingtonian Blvd.
    Ste. 500
    Gaithersburg, MD 20878
    USA
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