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- Celcuity's gedatolisib trial cuts death risk but misses investor expectationsCelcuity reported data from its Phase 3 VIKTORIA-1 trial evaluating gedatolisib in HR‑positive, HER2‑negative breast cancer with PIK3CA mutations. The trial enrolled 350 patients who had progresse…
- FDA issues draft guidance outlining data flexibilities for cell and gene therapy developersThe FDA released a draft guidance from its Center for Biologics Evaluation and Research (CBER) that clarifies how developers of cell and gene therapies can use existing data and prior knowledge in…