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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.

GSK upbeat on its return to oncology market

GSK upbeat on its return to oncology market

Luke Miels. Luke Miels says a positive result in this trial could see Zejula reaching a far wider patient population than Lynparza, which gained first line FDA approval in germline

Latest news

  • EMA sees approval numbers rise in 2018 EMA sees approval numbers rise in 2018

    The FDA’s faster approval rate is based on its sustained efforts to identify promising innovative drugs earlier, and work more closely with developers, via pathways such as the FDA Breakthrough ... Four medicines gained approval in 2018 following

  • Moderna CEO makes case for firm’s lofty valuation Moderna CEO makes case for firm’s lofty valuation

    The biotech announced this week It has filed for FDA approval to start a phase 2 trial of OX40L- targeting immuno-oncology drug mRNA-2416 in ovarian cancer, with mid-stage

  • Orphan drugs dominate FDA's record-breaking year Orphan drugs dominate FDA's record-breaking year

    drugs, driven on by new pharma and biotech science, and the FDA's determination to accelerate its review times. ... The FDA Commissioner recently reiterated his criticism of anti-competitive measures from originator companies which block biosimilars.

  • First-line ovarian approval cements AZ’s Lynparza lead First-line ovarian approval cements AZ’s Lynparza lead

    The new FDA approval means that Lynparza (olaparib) can be given to patients who are in complete or partial response to first-line treatment with platinum-based chemotherapy for ovarian, fallopian ... All three are already approved for maintenance in

  • Biogen files Tecfidera follow-up in the US Biogen files Tecfidera follow-up in the US

    Alkermes pocketed a $50m milestone payment from Biogen on the strength of preliminary comparative tolerability data, and will get another $150m if the drug is approved by the FDA. ... Earlier this month Indian drugmakers Lupin Labs and Shilpa Medicare

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Latest Intelligence

  • 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.

  • Alnylam’s big moment: bringing groundbreaking RNAi drugs to Europe Alnylam’s big moment: bringing groundbreaking RNAi drugs to Europe

    platform. Led by founder and CEO John Maraganore, Alynlam finally crossed the line in August when it gained FDA and EU approval for its first drug, Onpattro. ... disease which is seen as key for patients’ long term survival, and is already under review

  • Regeneron and Bluebird sign $100m cell therapies deal Regeneron and Bluebird sign $100m cell therapies deal

    Regeneron and its long-standing partners Sanofi look set to gain FDA approval for their PD-1 immunotherapy contender, cemiplimab in October, while Bluebird is poised to file its

  • Bluebird Bio: on the cusp of a gene therapy revolution Bluebird Bio: on the cusp of a gene therapy revolution

    Learning from the failures of Glybera and Strimvelis. When Spark Therapeutic’s Luxturna gained FDA approval last year, it was the first US-approved gene therapy, but Europe was years ahead ... Spark's Luxturna: already approved in the US, expected to

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