FDA sets back Travere's plans for kidney disease drug approval

FDA sets back Travere's plans for kidney disease drug approval

Source: 
Fierce Biotech
snippet: 

The FDA has crushed Travere Therapeutics’ hopes of seeking accelerated approval in a rare kidney disorder on the strength of existing interim data from a phase 3 clinical trial. Travere said it may have enough data to meet the FDA’s demands by the first half of next year.