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FDA`

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

BioMarin prepares for haemophilia A gene therapy data readout, filing

BioMarin prepares for haemophilia A gene therapy data readout, filing

However Valrox is undoubtedly generating the most anticipation, and the company says it now expects to submit it to the FDA via a potential accelerated approval, which it must apply for

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  • 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.

  • Launch trends 2019 Launch trends 2019

    2018 saw the FDA approve a record number of drugs, as well as an increasing number in orphan disease areas.

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