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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The end of the year should see a flurry of new products reaching the market to break new commercial ground or shake up their respective therapeutic areas. Here, Scrip takes a look at 12 of the more interesting approvals expected in the coming months, with the help of analysts at Biomedtracker.
Keeping Track: Veklury NDA Arrives At US FDA; Olinvyk Sees Approval; MAb Filings By Regneron, Y-mAbs
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
October was an active fundraising month for both start-up biopharma companies and more established privately held firms, ranging from $3m for Appili's drug for anaerobic infections to $270m for Harmony's rare disease programs.