- Reuters reports that the FDA greenlighted 46 new medicines in 2017, the highest tally in 21 years and more than double the total in 2016.
- 2017's total was actually 49 if cell therapies from Novartis (KYMRIAH) and Gilead Sciences (YESCARTA) and Spark Therapeutics' gene therapy LUXTURNA are included (all were approved under a different category).
- The primary reason for the high number of approvals was the FDA's accelerated review process for selected drugs. The number getting the greenlight this year may moderate a bit since several approvals expected this quarter were granted in Q4 2017.
- Many eyes are on Europe since the European Medicines Agency (EMA) will be moving to Amsterdam from London this year which may disrupt/delay approvals there. In 2017, the EMA backed 92 new drugs, including generics, up 12% from 2016's total of 81.
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