Y-mAbs Faces Delay In Pediatric Neuroblastoma With Refuse-To-File Letter
Omburtamab, for CNS metastases resulting from neuroblastoma, needs more clinical and CMC data for its rolling BLA to be reviewed. The company says timelines for lead candidate naxitamab should not be affected.
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In advisory committee briefing documents, the US FDA said control data was not comparable to the single-arm trial and the benefits of the monoclonal antibody were unclear.
Keeping Track: Novel Oncologics Submitted By Taiho, ImmunoGen, Y-mAbs; US FDA Declines Akebia’s Vadadustat
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The European Medicines Agency has added 13 new drugs to its list of products that are under review for potential pan-EU marketing approval.