Travere fails to convince regulators to consider accelerated approval for a rare kidney disease — again

Travere fails to convince regulators to consider accelerated approval for a rare kidney disease — again

Source: 
Endpoints
snippet: 

Travere Therapeutics will be asking itself that question after a second attempt to gun for accelerated approval was rejected by the FDA, the company announced Wednesday afternoon. The former Martin Shkreli biotech had attempted to push through its lead drug, sparsentan, to a speedy OK in a rare kidney disease, but regulators prefer the more methodical, full approval route.