Last year, the FDA’s Center for Drug Evaluation and Research (CDER) approved 19 new molecular entities, compared to 21 the year before. The CDER also approved six biologic license applications, up from three in 2008. New biologics accounted for 24% of new approvals, the highest percentage ever. The highest number of approvals were for cancer (five), neurological disorders (four), and autoimmune diseases and cardiovascular indications (three each). Nine priority reviews received approval, with six classified as orphan drugs. Novartis received three approvals, GlaxoSmithKline received two and Centocore Ortho Biotech, a Johnson & Johnson subsidiary, received two.

Source: Nature Reviews Drug Discovery