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Vericel Corporation

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Latest From Vericel Corporation

Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Gene Therapy Approvals

RSV Vaccine May Be On Market In 2023, CDC’s ACIP Anticipates

Panel expects to review five respiratory syncytial virus vaccines and vote on one or two of them in June 2023 and others four months later. Sanofi presents results of three clinical trials of its monoclonal antibody nirsevimab, which is on track to be the second RSV prophylaxis for infants.

Advisory Committees Vaccines

BioMarin Rolls Up Sleeves To Prepare For Roctavian’s EU Debut

The company plans to start in Germany with an outcomes-based payment model. But while a US FDA nod seems likely, analysts have been more cautious about calling US approval a done deal.

Gene Therapy Market Access

Sarepta’s Exondys 51 Successor On Clinical Hold, But Quick Resolution Expected

The FDA placed a hold on the Phase II study of SRP-5051, which uses the company’s next-generation peptide conjugation technology, but Sarepta thinks it can address safety questions in short order.

Drug Safety Clinical Trials
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Company Information

  • Industry
  • Pharmaceuticals
  • Medical Devices
    • Biomaterials
  • Biotechnology
    • Gene Therapy, Cell Therapy
    • Large Molecule
  • Other Names / Subsidiaries
    • Aastrom Biosciences, Inc.
    • Genzyme Biosurgery
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