New drug approvals were off to a slow start in 2010 but addressed indications outside the usual areas. In April, the first autologous cell therapy, Provenge (sipuleucel-T), was approved, and last month, Amgen's RANK ligand antagonist (denosumab) was also registered for marketing. Fingolimod, the first synthetic sphingosine-1-phosphate agonist in multiple sclerosis, was given a favorable recommendation, and positive trial data came in for the antisense drug, mipomersen, as well as ipilimumab, epratuzumab and pertuzumab, which addresses a new epitope on HER2.

FDA approvals by therapeutic indication

Notable regulatory approvals (March - June 2010)

Notable regulatory setbacks (March - June 2010)

Notable trial results (March - June 2010)

Notable upcoming approvals Q310