FDAsafety guidance83% confidence
Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement - FDA Safety Communication
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (lung cancer) as Roche.
Regulatory Analysis
Read the FDA’s recommendations related to Accolade pacemaker devices by Boston Scientific and a potential need for early device replacement.
Supporting Context
- Therapeutic area
- Oncology · KRAS G12C NSCLC
- Sub-indication
- Lung Cancer
Related signal: Roche's Divarasib Shows Best-in-Class Potential in Phase III NSCLC Trial