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Keeping Track: Novel Approvals For Diacomit, Takhzyro And Oxervate; CRLs For Mallinckrodt And Allergan

 
• By Michael Cipriano

The latest drug development news and highlights from our US FDA Performance Tracker.

A scorching hot August at the US FDA became even hotter this past week, as the agency gave its blessing to three more novel agents, all of which were orphan drugs: Biocodex's Diacomit (stiripentol), Shire PLC's Takhzyro (lanadelumab-flyo) and Dompé SpA's Oxervate (cenegermin-bkbj). All three are orphan drugs, and all three were reviewed under priority status.

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