Keeping Track: Four Novel Agents Clear FDA; Two Complete Response Letters Issued
Executive Summary
The latest drug development news and highlights from our FDA Performance Tracker.
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Breakthrough's Achilles Heel: Alexion’s Newly Acquired Kanuma Delayed By Manufacturing
FDA extends the PDUFA date for enzyme replacement therapy by three months so agency can review chemistry, manufacturing and controls information; another drug, Strensiq, is also pending at FDA without any action.