FDA News

Neurocrine Biosciences’ Rare Adrenal Disease Drug Receives Orphan Designation by the FDA

San Diego-based Neurocrine Biosciences, Inc. announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to its investigational congenital adrenal hyperplasia (CAH) drug. The agency granted orphan status to NBI-77860, a proprietary corticotropin releasing factor 1 (CRF) receptor antagonist for treatment of CAH, a disease that …

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FDA Panel Recommends Approval of Sandoz’s Biosimilar Version of Neupogen

A panel of advisors for the US Food and Drug Administration (FDA) has recommended approval of Novartis’ investigational biosimilar version of Amgen’s Neupogen (filgrastim). The agency’s independent Oncologic Drugs Advisory Committee (ODAC) voted 14-0 in favor of approving Novartis’ biosimilar version of Amgen’s cancer drug Neupogen, which boosts white blood …

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