DANSK BIOTEK organizes four major plenary meetings for our members throughout the year to increase our members' knowledge regarding specific biotech topics and to facilitate networking. The events usually take place in February, May, September and November.

We also organize approximately four "saloon" meetings annually. They are small, intimate, "meet the expert" meetings with typically 6-20 participants advocating more in-depth discussion and knowledge-sharing on specific themes.

08 Jun 2020

Y-mAbs Announces U.S. FDA Acceptance of Biologics License Application for Danyelza™ (naxitamab) for the Treatment of Neuroblastoma for Priority Review

Y-mAbs Therapeutics, Inc., a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the Biologics License Application for Danyelza™ (naxitamab) for the treatment of patients with relapsed/refractory high-risk neuroblastoma has been accepted for priority review by the U.S. Food and Drug Administration (“FDA”). The FDA set an action date of November 30, 2020, under the Prescription Drug User Fee Act. The Agency also indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application.

Read the full press release here

  • PDF - Y-mAbs Announces U.S. FDA Acceptance of Biologics License Application for Danyelza™ (naxitamab) for the Treatment of Neuroblastoma for Priority Review

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