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Fennec Pharmaceuticals Resubmits NDA for PEDMARK™

Fennec Pharmaceuticals Resubmits NDA for PEDMARK™

Fennec Pharmaceuticals has resubmitted their New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PEDMARK™, a unique sodium thiosulfate formulation. PEDMARK is designed to prevent ototoxicity caused by cisplatin chemotherapy in patients under...
FDA Places Restrictions for Obeticholic Acid (Ocaliva)

FDA Places Restrictions for Obeticholic Acid (Ocaliva)

The U.S. Food and Drug Administration (FDA) has placed restrictions on the use of obeticholic acid (Ocaliva of Intercept Pharmaceuticals) in patients with primary biliary cholangitis (PBC) and advanced cirrhosis due to risk for serious liver injury. The restriction...