Vertex kidney disease drug faces infection risk scrutiny ahead of FDA decision
read at STAT ↗RegulatoryNeutral
Vertex's kidney disease therapy is expected to receive FDA approval, with the agency's decision scheduled for Nov 30.
A previously undisclosed pause rule has drawn attention, raising concerns about infection risk and possible label implications for the drug.
The issue is being highlighted as kidney specialists convene at the American Society of Nephrology meeting, underscoring heightened interest from investors and analysts.
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This writeup was produced by pharmadog from original reporting by STAT.
Original headline: “STAT+: Vertex kidney disease drug scrutinized for infection risk”
read at STAT ↗511 words · retrieved 35m ago
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