Johnson & Johnson (J&J) announced today that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to nipocalimab to reduce the risk of FNAIT in women during pregnancy.

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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