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Protalix BioTherapeutics, Inc.

http://www.protalix.com

Latest From Protalix BioTherapeutics, Inc.

Keeping Track: Early Thanks Given By ImmunoGen, Provention Bio; More PD-1/L1 Combo Approvals

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

US FDA Performance Tracker Approvals

Protalix Plans US Resubmission For ERT For Fabry After Positive Phase III Trial Results

Clinical Trials Complete Response Letters

New EU Filings Include Tibsovo Resubmission, Pegunigalsidase & Daprodustat

Servier is trying again with Tibsovo in the EU, while Protalix is using June 2021 data to support its filing for pegunigalsidase, which the US regulator turned down last April.

Europe Drug Review

US FDA’s 2022 Novel Agent Actions Suggest Acceleration In Use Of Complete Response Letters

COVID does not appear to be a driving factor, and letters are split almost equally between clinical and quality concerns.

Complete Response Letters Drug Approval Standards
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Biotechnology
    • Large Molecule
    • Synthesis Technologies, Production Processes
    • Transgenics
  • Other Names / Subsidiaries
    • Protalix Ltd.
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