Posted by Michael Wonder on 06 Dec 2018
FDA breaks NME approval record in 2018
6 December 2018 - FDA has approved 55 new molecular entities so far in 2018, surpassing in mid October the total of 46 that were approved in 2017.
With almost four weeks left in the year, 2018 has already topped the 53 that were approved in 1996, the all-time high in FDA's published data.
Approvals of orphan drugs shot up to 32, exceeding the total number of approvals for all but eight of the past 26 years. Last year's total was 18. About a third of the orphan drugs were approved for cancer indications; only three of this year's cancer approvals were for non-orphan cancers.
