Liver Injury Case Sparked Flurry Of Concern Late In Praluent Review
MedWatch report of hepatotoxicity prompted two 'urgent information requests' to sponsors a month before alirocumab user fee goal date.
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A listing of the Drug Review Profile series articles published in the Pink Sheet.
FDA's worries about sufficiency of long-term safety data were exacerbated by 'weak' bridging data between two formulations; agency decided against refuse-to-file action but directed Amgen to immediately begin new PK/PD study.
Sanofi and Regeneron's 'extended negotiations' with FDA on requirements would later apply to Amgen's Repatha.