1. Pink Sheet

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.

For those keeping track of the novel approval numbers, there were no previous submission announcements for Diacomit and Oxervate, so their approvals add to any projected total for the year

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