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FDA approval

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

BeiGene gets speedy US review for lymphoma drug zanubrutinib

BeiGene gets speedy US review for lymphoma drug zanubrutinib

First US filing is major milestone for Chinese firm. Chinese biopharma company BeiGene has claimed priority review status for its BTK inhibitor zanubrutinib from the FDA, setting up a possible approval ... Zanubrutinib was previously awarded fast-track

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  • The Cystic Fibrosis Buyers’ Club The Cystic Fibrosis Buyers’ Club

    The movement proved to be hugely influential, and by the early 1990s its activism had spurred the FDA to introduce ‘accelerated approval’ that allowed experimental yet promising drugs to be made ... The FDA hadn’t been willing to override its

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

    Frontline monotherapy in NSCLC. The next regulatory milestone for Keytruda will be FDA approval as a first-line monotherapy in locally advanced or metastatic non-squamous or squamous non-small cell ... The FDA had been expected to grant approval in

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

    Vitrakvi(larotrectinib) gained FDA approval in late November to treat any solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, which causes the production of TRK, a family ... The product gained EMA approval in November and

  • AstraZeneca’s oncology renaissance AstraZeneca’s oncology renaissance

    from clinical trials to FDA approval in just over two years. ... On one hand, it has scored a major success this year by gaining US and EU approval as a monotherapy maintenance treatment for NSCLC patients with inoperable stage 3 disease, ie

  • Deal Watch October 2018

    The termination comes as a consequence of patent infringement litigation which has placed a stay on the FDA’s approval of the biosimilar, Lusduna Nexvue, in the US.

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