Ocaliva’s Takedown by FDA Panel

MedPage Today) — Without sufficient data to work with, FDA advisors were strongly inclined against giving full approval of obeticholic acid (Ocaliva or OCA) in primary biliary cholangitis (PBC). On Friday, the agency’s Gastrointestinal Drugs…

MedPage Today) — Without sufficient data to work with, FDA advisors were strongly inclined against giving full approval of obeticholic acid (Ocaliva or OCA) in primary biliary cholangitis (PBC).
On Friday, the agency’s Gastrointestinal Drugs…
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