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FDA approvals 2018

This page shows the latest FDA approvals 2018 news and features for those working in and with pharma, biotech and healthcare.

FDA clears Sobi’s Gamifant for ‘hyper-inflammation’ disease

FDA clears Sobi’ s Gamifant for ‘ hyper-inflammation’ disease. Approval adds to growing US portfolio. ... In non-responders, Gamifant achieved a 63% response, and in 70% of cases patients were well enough to proceed to a stem cell transplant,

Latest news

  • Roche’s new flu pill Xofluza approved in US Roche’s new flu pill Xofluza approved in US

    The FDA has approved Roche’s new flu treatment Xofluza (baloxavir marboxil), the first new antiviral drug in nearly 20 years. ... The FDA approved the treatment well ahead of its 24 December deadline, mindful that it could help as the flu season gets

  • Leadiant gets FDA OK for bubble boy disease drug Leadiant gets FDA OK for bubble boy disease drug

    Leadiant gets FDA OK for bubble boy disease drug. New therapy will rival Orchard's Strimvelis. ... Italy’s Leadiant Biosciences has claimed FDA approval for a new drug for adenosine deaminase severe combined immune deficiency (ADA-SCID) – also known

  • FDA approval gained, Pfizer sets sights on first-line NSCLC market FDA approval gained, Pfizer sets sights on first-line NSCLC market

    FDA approval gained, Pfizer sets sights on first-line NSCLC market. Vizimpro could challenge Tagrisso, survival data will be key. ... Pfizer’s gruelling trek to bring EGFR inhibitor dacomitinib to market has finally paid off, with the FDA approving it

  • Teva wins FDA OK for crucial migraine drug Teva wins FDA OK for crucial migraine drug

    Teva wins FDA OK for crucial migraine drug. Vital to Teva's turnaround, Ajovy will challenge Novartis/Amgen's Aimovig. ... Teva would have been earlier to market but the FDA review for its products was delayed by three months while it sorted out some

  • AZ nabs US approval for new leukaemia drug Lumoxiti AZ nabs US approval for new leukaemia drug Lumoxiti

    AstraZeneca has chalked up another product approval in its oncology franchise, getting an FDA nod for Lumoxiti, a new CD-22-targeted drug for rare cancer hairy cell leukaemia (HCL). ... 14th September 2018.

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