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Keeping Track: CDER Approves Its First Two Novel Agents Of 2019

 
• 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: It took a month, but the US FDA finally issued its first novel approvals of 2019. The first went to Evolus Inc.'s Jeuveau (prabotulinumtoxinA-xvfs), a new competitor to Allergan PLC's Botox (onabotulinumtoxinA), and the second went to Sanofi's Cablivi (caplacizumab-yhdp) as the first treatment specifically indicated for acquired thrombotic thrombocytopenic purpura (aTTP).

Another drug is headed for a review under the real-time oncology review (RTOR) pilot program, as Genentech Inc

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