regulatory approval
BMS's Breyanzi Gains European Approval as Third-Line Treatment for Follicular Lymphoma
The EC approved the CAR T-cell therapy based on data from a Phase II study showing a 94 percent complete response rate.
CHMP Recommends Approval of AstraZeneca, Daiichi Sankyo's Enhertu in HER2-Ultralow Breast Cancer
Approval would expand the use of Enhertu to breast cancer patients with nearly undetectable HER2 levels in their tumors.
UK's NICE Approves Blincyto as Frontline Consolidation Treatment for Certain Leukemia Patients
Blincyto plus chemo was approved for adult patients with Ph-negative, CD19-positive, and MRD-negative B-cell precursor acute lymphoblastic leukemia.
Merck's Welireg Approved in Europe for Von Hippel-Lindau-Associated Cancers
The European Commission granted approval for von Hippel-Lindau-associated renal cell carcinoma, CNS hemangioblastomas, or pancreatic neuroendocrine tumors.
EC Approves Amgen's Blincyto as Consolidation Treatment for Certain Newly Diagnosed Leukemia Cases
The EC's decision was based on results from a Phase III trial of Blincyto with multiphase consolidation chemotherapy.