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Even before a new law granted FDA authority to require studies be underway before accelerated approval, review divisions have, in some cases, given sponsors years of advance notice on expectations around study timing, according to a Pink Sheet review of NME accelerated approvals.

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Takeda Pays Big For De-Risked HutchMed CRC Drug

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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Biotechnology
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    • Large Molecule
      • Antibodies
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