Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years
ISB 2001 demonstrated a favorable safety and tolerability profile, and an overall response rate (ORR) of 75% in r/r MM
GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally
Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy
At 24 months, data from the Phase 1 exPDite trial continue to show a favorable safety profile in all 12 participants in the trial’s high and low dose cohorts
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
The primary objective was to evaluate safety and tolerability of Ropanicant in patients with MDD
ALS patients experience neuroinflammation and rapid neurodegeneration
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