FDAapproval65% confidence
FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer
Source: FDA
Why This Matters
Why this matters: provides agency context on approval that may shape timing or evidence expectations for Shanghai Junshi Bioscience.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · Nasopharyngeal Carcinoma
- Sub-indication
- General
Related signal: Phase I Study of JS001sc in Advanced Nasopharyngeal Carcinoma Shows Focus on Safety and Tolerability