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Drug pipeline: 2Q15

An Erratum to this article was published on 08 October 2015

This article has been updated

US Food and Drug Administration approvals seem to have waned from even the previous quarter when eight drugs with novel mechanisms were approved. Yet breakthrough therapy designation remains popular among drug developers and regulators as the designation moves into less trafficked areas. Two monoclonal antibodies for lowering cholesterol were neck and neck with PDUFA dates mere months apart, with one gaining approval already in the US, the other in Europe as this page was being prepared. Biosimilars are starting to take root as well.

Historic US regulatory approvals by lead indication area

Notable clinical trial results (2Q15)

Notable upcoming regulatory decisions (3Q15)

Notable regulatory approvals (2Q15)

Notable regulatory setbacks (2Q14)

Change history

  • 06 October 2015

    In the version of this article initially published, in the “Notable clinical trial results (2Q 2015)” table, clinical trial data for the drug Glembatumumab vedotin was said to be phase 3. It was phase 2, not phase 3, data. The error has been corrected in the HTML and PDF versions of the article.

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DeFrancesco, L. Drug pipeline: 2Q15. Nat Biotechnol 33, 795 (2015).

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