Keeping Track: Three Oncologics, A New Migraine Preventive, And First LPAD Antibiotic Clear US FDA

 
• By Michael Cipriano, Bridget Silverman, and Mary Jo Laffler
  
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The latest drug development news and highlights from our FDA Performance Tracker.  

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It's hard to keep the US regulatory and approval news brief this week: The Center for Drug Evaluation and Research’s novel agent approvals count for 2018 reached 41 with the approval of three new oncologics – Regeneron Pharmaceuticals Inc. and Sanofi’s Libtayo (cemiplimab-rwlc), Pfizer Inc.’s Vizimpro (dacomitinib) and Verastem Inc.’s Copiktra (duvelisib) – as well as Eli Lilly & Co.’s migraine preventative Emgality (galcanezumab-gnlm).

The agency also closed out the week with its first approval under the Limited Population Pathway for antibacterial and antifungal...

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