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Complete Response Letter
Pharma
FDA shoots down Intercept's bid for full approval of Ocaliva
In the wake of an unfavorable advisory committee meeting, Intercept's bid to win full approval for its liver disease drug Ocaliva has come up short.
Fraiser Kansteiner
Nov 12, 2024 2:12pm
FDA stymies Camurus' drug over 3rd-party manufacturing issues
Oct 22, 2024 9:53am
Zealand's hypoglycemia med rebuffed again by FDA
Oct 9, 2024 9:19am
Zevra snags FDA approval for new lysosomal storage disorder med
Sep 20, 2024 1:54pm
Novo won't file for IcoSema approval in US
Aug 13, 2024 1:40pm
Inside the FDA concerns that sank Hengrui's PD-1 drug filing
Jul 16, 2024 4:50pm
