August 13th 2020
The FDA’s Oncologic Drugs Advisory Committee voted 8 to 2 in favor of approving remestemcel-L for the treatment of children with steroid-refractory acute graft-versus-host disease.
August 12th 2020
Numerous analyses conducted over the past few years have underscored a serious issue in clinical cancer trials that needs to be addressed: a lack of racial and ethnic diversity among participants.
August 11th 2020
The FDA has issued a complete response letter to Fennec Pharmaceuticals regarding its new drug application for a unique formulation of sodium thiosulfate (Pedmark) for the prevention of cisplatin-induced ototoxicity in patients from 1 month to less than 18 years of age with localized, nonmetastatic, solid tumors.
August 7th 2020
The FDA has granted a priority review designation to a new drug application for a unique formulation of sodium thiosulfate for the prevention of cisplatin-induced ototoxicity in patients from 1 month to less than 18 years of age with localized, nonmetastatic, solid tumors.
August 6th 2020
The biologics license application for the investigational B7-H3–targeting monoclonal antibody omburtamab for use in pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma has been submitted to the FDA under the agency’s Rolling Review process.
July 21st 2020
The FDA’s Oncologic Drugs Advisory Committee has scheduled a date to review data supporting the biologics license application for remestemcel-L as a treatment for children with steroid-refractory acute graft versus host disease.
June 28th 2020
Following the arrival of the coronavirus disease 2019 pandemic, St. Jude Children's Research Hospital launched the first Global COVID-19 Observatory and Resource Center for Childhood Cancer.
June 3rd 2020
The FDA has granted a priority review designation to a biologics license application for the investigational, humanized monoclonal antibody naxitamab (Danyelza) for the treatment of patients with relapsed/refractory high-risk neuroblastoma.
May 29th 2020
The use of real-time comprehensive profiling provides valuable diagnostic information and identifies potential therapeutic targets in adults with malignancies, but this process remains widely underutilized for pediatric patients and represents a significant unmet need.
April 4th 2020
A Biologics License Application has been filed with the FDA for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma.
