FDA authorizes an expanded access treatment protocol after the oral RAS(ON) inhibitor doubled survival for metastatic patients in a phase 3 trial.
Approval was based on findings from the phase 3 VERITAC-2 trial showing significantly improved PFS for patients with ESR1-mutated disease.
A new FDA regulatory pathway could accelerate approval of psychedelic therapies for resistant depression and PTSD, and ...
Using a more pragmatic classification system than the current standard provided clearer discrimination between disease ...
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