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

 
• By Derrick Gingery

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.

flexibility
FDA flexibility may not be extensive enough to approve I-omburtamab. • Source: Shutterstock

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