Company Statement on FDA Advisory Committee Meeting - BioSpace
FDA's GIDAC discussed Intercept's sNDA for OCALIVA for PBC treatment; Intercept disappointed by the committee's vote, emphasizing OCALIVA's clinical benefits. FDA to make final decision by October 15, 2024.
Reference News
Company Statement on FDA Advisory Committee Meeting - BioSpace
FDA's GIDAC discussed Intercept's sNDA for OCALIVA for PBC treatment; Intercept disappointed by the committee's vote, emphasizing OCALIVA's clinical benefits. FDA to make final decision by October 15, 2024.