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Chiesi USA Inc.

Division of Chiesi Farmaceutici SPA
www.crtx.com

Latest From Chiesi USA Inc.

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.

US FDA Performance Tracker Approvals

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

Keeping Track: US FDA Receives Submissions Galore As Year Ends

A roundup of new applications submitted to FDA’s Center for Drug Evaluation and Research.
Drug Review Regulation
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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