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Keeping Track: New MCL Treatment Calquence, Submissions Galore, And A Breakthrough Designation For GSK

 
• By Michael Cipriano

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

Keeping Track Feature image

Here's your news in brief:AstraZeneca PLC has reeled in a US FDA approval for its mantle cell lymphoma (MCL) treatment Calquence (acalabrutinib), bringing the agency's new drug approval count for 2017 to 35.

It was another busy week of submissions, with sponsors filing several new molecular entities and supplemental applications that are likely to receive priority review

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