OJEMDA„ (tovorafenib) launch underway following U.S. FDA accelerated approval for relapsed or refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG) First prescriptions received in the U.S. ...
Pediatric Brain Tumor Foundation celebrates FDA approval of Day One Biopharmaceuticals™ OJEMDA„, new treatment for common pediatric brain tumor type
XOMA is entitled to a mid-single digit royalty on global OJEMDA„ sales First and only FDA-approved type II RAF inhibitor for patients with relapsed or refractory pLGG harboring a BRAF fusion or...
Day One drug for common childhood brain tumor approved by FDA
Day One’s OJEMDA™ (tovorafenib) Receives US FDA Accelerated Approval for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG), the Most Common Form of Childhood Brain Tumor
Day One's OJEMDA„ (tovorafenib) Receives US FDA Accelerated Approval for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG), the Most Co
XOMA Earns $5M Milestone Upon Acceptance of Day One™s Tovorafenib NDA for pLGG
The FDA has granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.
Overall response rate (ORR) greater than 50% across three assessment criteria Median duration of tovorafenib treatment of 15.8 months as of June 5, 2023, with 66% of patients remaining on treatment ...
BRISBANE, Calif., May 25, 2023 (GLOBE NEWSWIRE) -- In a release issued under the same headline earlier today by Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN), please note that in the second...