The number of small-molecule approvals declined more sharply than that of biologics over the past decade. However, new targets, such as atrium-specific K+ channel, phosphodiesterase-4 and renal Na+-glucose co-transporter, continue to open up new opportunities. Such novel targets are not without risk, as Eli Lilly found this quarter when its gamma-secretase inhibitor failed to meet its endpoints in Alzheimer's. Meanwhile, MannKind's inhaled insulin, Afrezza, demonstrated both efficacy and safety in a key trial. Approvals are also expected for Benlysta (belimumab), ipilimumab and Bydureon (exenatide LAR).

FDA approvals by drug molecule type

Notable regulatory approvals (June-September 2010)

Notable development setbacks (June-September 2010)

Notable trial results (June-September 2010)

Notable upcoming approvals (Q4 2010)