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.
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Advocates also worry that long follow-up times could prevent participation in future clinical trials.
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.
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.