FDA
Doctors and patient advocates supporting pretreatment testing at times challenged FDA and other experts who aren't swayed by available evidence.
Atara Biotherapeutics Receives FDA Complete Response Letter for Ebvallo
The FDA didn't approve the therapy in EBV-positive posttransplant lymphoproliferative disease due to findings at a third-party manufacturing facility.
FDA Approves AstraZeneca, Daiichi Sankyo's Datroway for HR-Positive, HER2-Negative Breast Cancer
This marks the first US approval for AstraZeneca and Daiichi Sankyo's Trop-2-directed antibody drug conjugate.
Amgen's Lumakras, Vectibix Net FDA Approval in KRAS G12C-Mutant Colorectal Cancer
The FDA also approved Qiagen's Therascreen KRAS RGQ PCR kit as a companion diagnostic to identify KRAS G12C-mutant patients.
Foundation Medicine Assay Nabs FDA Approval as CDx for Ojemda in Pediatric Patients
The FoundationOne test can be used to identify patients with relapsed or refractory BRAF-altered pediatric low-grade glioma who may be eligible for therapeutic options.
Jan 13, 2025
Roche Gets FDA Clearance for B-Cell Lymphoma Test
Nov 27, 2024