The US Food and Drug Administration continued to approve drugs at a faster pace than during the same time last year. Small molecules were particularly prominent, including Roche's B-RAF V600E mutation-specific Zelboraf (vemurafenib), which was approved for melanoma treatment just 99 days after filing. Seattle Genetics's antibody-drug conjugate, Adcetris (brentuximab vedotin), was also approved for lymphoma. Several biologics and novel therapeutics made progress in early stages, including AVI BioPharma's exon-skipping-inducer, eteplirsen, for muscular dystrophy, Baxter's autologous stem cell therapy for cardiovascular diseases and Novavax's influenza vaccine comprising virus-like particles. Several companies announced yet to be published late-stage results: Roche/Genentech's pertuzumab met its endpoints in breast cancer, Sanofi's alemtuzumab showed efficacy in the new indication of multiple sclerosis and Dynavax's hepatitis B virus vaccine Heplisav was protective. Regulatory decisions on JAK-STAT pathway inhibitor INCB 18424 (ruxolitinib) for treating myeloproliferative disorders and myelofibrosis and Bristol-Myers Squibb's dapagliflozin in insulin-independent diabetes are eagerly awaited.

Notable regulatory approvals (Q3 2011)

Notable regulatory setbacks (Q3 2011)

Notable upcoming regulatory decisions (Q4 2011-Q1 2012)

FDA approvals by drug molecule type

Notable trial results (Q3 2011)