J&J: Fast Track designation for nipocalimab
The laboratory points out that FNAIT is a rare and serious disease that occurs when a pregnant person's immune system mistakenly attacks the platelets of a developing fetus. This immune response can lead to impaired clotting capacity and bleeding, posing a significant risk to the fetus or newborn baby", adds J&J.
As a reminder, the FDA's Fast Track designation enables drugs with the potential to address unmet medical needs for serious or life-threatening diseases to be reviewed in a shorter timeframe.
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