Heavy menstrual bleeding in adolescents: Normal variant or a bleeding disorder?

Initial approval for maralixibat was granted on March 13, 2024, to treat PFIC patients aged 5 years and older.

The third and final episode in our series looks at what is in the pipeline as well as a discussion around FDA guidance.

With the acceptance of the BLA, a new PDUFA date of January 7, 2025 has been set.

Risk for cataract development was assessed at specific follow-up durations of 1 year, 2 years, 5 years, and 20 years following the index date, with an increased risk of cataracts development among patients aged younger than 18 years present at each time point.