US Food and Drug Administration approvals slowed in the second quarter of 2013, with only three new molecular entities. A growing number of novel sustained-release delivery vehicles are coming to market. AIDS prevention and treatments suffered setbacks, with suspension of a prime boost DNA vaccine and manufacturing problems for a pharmacokinetics enhancer previously approved for HIV reverse transcriptase–integrase inhibitor combinations. The European Medicines Agency will be reviewing a number of biosimilars in Q4 2013.

FDA approvals by lead indication area

Notable regulatory approvals (Q2 2013)

Notable clinical trial results (Q2 2013)

Notable regulatory setbacks (Q2 2013)

Notable upcoming regulatory decisions (Q4 2013)