Alfasigma S.p.A.

The new drugs that hit the market in 2024 included medicines to address an array of high unmet medical need, but the US Food and Drug Administration approval of several drugs for liver disease put a s

The new drugs that hit the market in 2024 included medicines to address an array of high unmet medical need, but the US Food and Drug Administration approval of several drugs for liver disease put a s

One of the last lines of defense against withdrawal of Ocaliva’s accelerated approval failed when the US Food and Drug Administration issued a complete response letter for Intercept Pharmaceuticals ’

Intercept Pharmaceuticals, Inc. may struggle to preserve the future of its primary biliary cholangitis drug Ocaliva (obeticholic acid) following the US Food and Drug Administration’s negative review