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Chiesi USA Inc.

Division of Chiesi Farmaceutici SPA
www.crtx.com

Latest From Chiesi USA Inc.

US FDA, Advisory Committees Rarely Disagree

A Milbank Quarterly study and a Pink Sheet analysis show that disagreement between the US FDA and its advisory committee meetings doesn't happen often; it is even rarer for the agency to approve a drug against the advice from a panel.
Advisory Committees Approvals

Keeping Track: FDA OKs AMAG's Vyleesi, But Bronchitol And Quizartinib Draw CRLs

The latest drug development news and highlights from our US FDA Performance Tracker.

Approvals Drug Review

Bronchitol Gets Narrow Approval Vote From Advisory Cmte., Leaving US FDA Host Of Issues To Consider

Pulmonary-Allergy Drugs Advisory Committee votes 9-7 that the benefits of Pharmaxis' cystic fibrosis drug outweigh its risks, leaving the FDA with a muddled verdict.

 

Advisory Committees Respiratory

Chiesi Takes CF Product To Advisory Cmte. With Modest Efficacy, Many Questions

Bronchitol is set to make its second appearance before a US FDA advisory committee, and Chiesi hopes to rely on the drug’s novel mechanism of action and the unmet need in cystic fibrosis to overcome the agency’s concerns about the underlying clinical data.

Advisory Committees Respiratory
See All

Company Information

  • Industry
  • Pharmaceuticals
    • Specialty Pharmaceuticals
  • Therapeutic Areas
  • Non-Specific
  • Alias(es)
  • Cornerstone Therapeutics Inc.
  • Cornerstone BioPharma Inc.
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Chiesi Farmaceutici SPA
  • Senior Management
  • Ken McBean, General Manager
  • Contact Info
  • Chiesi USA Inc.
    Phone: (888) 661-9260
    1255 Crescent Green Dr.
    Ste. 250
    Cary, NC 27518
    USA
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