regulatory guidance
FDA Platform Designation Program Could Ease Path to Market for Gene-Editing Therapies
In a draft guidance, the agency outlined how the well-understood and reproducible components of genetic medicines could qualify as platform technologies.
UK's NICE Expands Tumor Profiling Recommendations for Guiding Adjuvant Chemo in Early Breast Cancer
Previously, NICE recommended EndoPredict, Prosigna, and Oncotype DX for node-negative breast cancer only, but the new guidance includes lymph node-positive disease.
NICE Recommends Novartis' BRAF, MEK Inhibitor Combo for BRAF-Mutant Pediatric Glioma
The UK's National Institute for Health and Care Excellence recommended the combination treatment for pediatric patients with BRAF V600E-mutant low- or high-grade glioma.
An advisory committee on Friday will consider whether minimal residual disease can reliably predict if multiple myeloma drugs are benefiting patients.
FDA Wants Expert Input on Benefits, Risks of CAR T Therapy in Earlier-Line Multiple Myeloma
Ahead of an advisory committee meeting Friday, the agency has noted concerns about the risk of early death seen with BMS's Abecma and Janssen's Carvykti in trials.