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Y-mAbs Therapeutics Inc.

http://www.ymabs.com/

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Will 2022 Be US FDA’s Year Of ‘No’? Approval Rate For Novel Agents Plunged In First Half

With 19 novel approvals and 14 complete response letters in the first half of 2022, the year is shaping up to be a turnabout from the big approval counts and rare CRLs of the recent approvals boom years.

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Advisory committee supports further research on end-of-induction response as an early interim clinical endpoint for drugs in treatment of high-risk neuroblastoma. FDA has approved two drugs for this rare disease in children, who have a 40-50% chance of long-term survival.

Advisory Committees Clinical Trials

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Company Information

  • Industry
  • Pharmaceuticals
  • Biotechnology
    • Large Molecule
      • Antibodies
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    • Y-mAbs Therapeutics A/S
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