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FDA

This page shows the latest FDA news and features for those working in and with pharma, biotech and healthcare.

Genfit claims FDA breakthrough status for liver disease drug

Genfit claims FDA breakthrough status for liver disease drug

Elafibranor up for speedy US review. Genfit’s most advanced liver disease drug elafibranor has today achieved a breakthrough tag from the US FDA following positive data from a phase 2 ... The FDA’s decision to grant elafibranor the Breakthrough

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  • Vertex: a vision of treating all CF patients worldwide draws closer Vertex: a vision of treating all CF patients worldwide draws closer

    with sickle cell disease or beta thalassemia with FDA Fast Track Designation.

  • Cell and gene therapy Cell and gene therapy

    Interest in cell and gene therapies is undeniable. In January, US FDA Commissioner Scott Gottlieb outlined policies designed to accommodate an anticipated surge in cell and gene therapy submissions.

  • 2019: CRISPR and therapeutic gene editing comes of age 2019: CRISPR and therapeutic gene editing comes of age

    The FDA placed the CTX001 programmed in beta thalassemia and a planned trial in sickle cell disease on a clinical hold shortly afterwards, but relaxed that last October. ... tested in gene therapies (and the technology which caused the FDA to raise

  • Immuno-oncology in 2019: the rapid evolution continues Immuno-oncology in 2019: the rapid evolution continues

    In December the FDA approved its use in combination with Avastin and chemotherapy in non-squamous NSCLC patients, based on results from the IMpower150 study. ... On 28 December, Keytruda gained FDA clearance for use in Merkel cell carcinoma.

  • Drug launches to watch in 2019 Drug launches to watch in 2019

    GW Pharma gained an historic approval for its drug Epidiolex from the FDA in June last year, becoming the first ever prescription medicine derived from cannabis. ... The product gained EMA approval in November and FDA approval on 26 December.

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