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accelerated approval

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

AstraZeneca’s Imfinzi fails first-line bladder cancer test

AstraZeneca’s Imfinzi fails first-line bladder cancer test

The failed study sets back AZ’s plans to expand Imfinzi into the first-line bladder cancer category, although it has already been granted an accelerated approval in the US for ... Keytruda became the first checkpoint inhibitor to get a green light in

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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

  • AstraZeneca: building a new ‘open innovation’ pharma company AstraZeneca: building a new ‘open innovation’ pharma company

    Two of these five new launches received accelerated approval, confirming their innovative status, plus the firm also clocked up 14 other regulatory approvals across indication expan- sion and LCM projects in

  • Chinese biotech’s global ambitions Chinese biotech’s global ambitions

    has just achieved a landmark approval in China for its own ‘home-grown’ cancer medicine. ... BeiGene is preparing to submit in the first half of 2019 a New Drug Application (NDA) to pursue an accelerated approval of zanubrutinib for WM patients.

  • Europe vs the US: New drug product approvals Europe vs the US: New drug product approvals

    During 2016, special approval procedures like conditional and accelerated approval pathways were issued for seven of the new approvals in the EU, the majority in oncology and for orphan diseases. ... In 2016 special approval pathways and designations

  • Curbing the rise of drug resistance Curbing the rise of drug resistance

    Microbes have an extraordinary capacity for developing resistance, accelerated by the over-use of anti-microbials in clinical and agricultural practice. ... Therapeutic areas such as oncology have already enjoyed accelerated approval times to jump

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