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Y-mAbs Therapeutics Inc.

http://www.ymabs.com/

Latest From Y-mAbs Therapeutics Inc.

BrainStorm Hoping For Advisory Committee After FDA Refuses To File BLA For Its ALS Cell Therapy

BrainStorm, which has a history of antagonizing FDA with direct appeals to patients for NurOwn, tells investors that public elements of an adcomm could be ‘persuasive,’ but first step will be formal meeting request to try to overcome the RTF. Firm sees Relyvrio as template for success.

Neurology Drug Approval Standards

Crucial Moment In EU For Sanofi/GSK’s COVID-19 Vaccine, Amicus’s AAT-GAA & Y-mAbs’ Omburtamab

Vidprevtyn, from Sanofi/GSK, and drugs from Amicus and Y-mAbs are nearing the end of the European Medicines Agency review cycle. They are among the products scheduled for discussion this week by the CHMP, the EMA committee that decides whether drugs should be granted pan-EU approval.

Drug Review Europe

Y-mAbs’ I-Omburtamab Offers Another Example Of The Limits To US FDA’s Regulatory Flexibility

Even in a rare disease with no approved treatments, the agency shows once again that without clear efficacy data, FDA has few options for approval.

Advisory Committees Review Pathway

US FDA’s ODAC: The Advisory Committee That Can Only Say ‘No’

It has been more than two years since a sponsor went before the Oncologic Drugs Advisory Committee and won a favorable vote on approval of a new drug application. Can FDA really expect an advisory committee to keep saying ‘no’ all the time?

Advisory Committees Drug Approval Standards
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Company Information

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