Tags : Naxitamab

Y-mAbs Reports the US FDA’s Acceptance of Priority Review for

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 […]Read More

Y-mAbs Reports the Submission of Naxitamab’s BLA to the US

Shots: Y-mAbs has submitted the BLA the US FDA under the FDA’s Rolling Review process for naxitamab following the market closure on Mar 31, 2020 The BLA submission is based on two P-II studies, 201 and 12-230 assessing the safety & efficacy of the therapy, which the company expects to present at a venue later […]Read More

Y-mAbs Reports Initiation of Rolling Review of BLA for Naxitamab

Shots: In Aug, 2018 naxitamab received the US FDA’s Breakthrough Therapy Designation for the treatment of high-risk neuroblastoma The rolling review process of the US FDA provides to submit individual portions of the BLA for review, rather than waiting until all portions are completed and submitted to the FDA for review Naxitamab is an anti-GD2 […]Read More