Shots:

• The US FDA has accepted the Danyelza’s BLA for PR to treat patients with relapsed/refractory high-risk neuroblastoma with its anticipated PDUFA date as Nov 30- 2020
• The company divulges in its BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application
• If approved- Danyelza can address the unmet medical needs for children with r/r high-risk neuroblastoma. Y-mAbs has exclusively licensed Danyelza from MSK- that has institutional financial interests in the product

Click here to read full press release/ article | Ref: PRNewswire | Image: Y-mAbs