Y-mAbs Reports the US FDA’s Acceptance of Priority Review for Danyelza’s (naxitamab) BLA to Treat Neuroblastoma

 Y-mAbs Reports the US FDA’s Acceptance of Priority Review for Danyelza’s (naxitamab) BLA to Treat Neuroblastoma

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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