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Orphan Drugs Compose Majority Of Novel US Approvals For First Time Ever In 2018

 
• By Michael Cipriano

Orphan drugs and priority reviews achieved historic highs in CDER's 2018 novel approval class, but share of products with breakthrough therapies took a slide. 

The young chimney sweep in black and white - Image

While the Center for Drug Evaluation and Research's (CDER's) record-setting number of novel product approvals stole many of the end-of-year headlines in 2018, the new class of medications also set a first for orphan drugs.

Of the 59 novel drugs and therapeutic biologics CDER cleared last year, 35 (59%) were orphan products. It is the...

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