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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.

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

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  • 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.

  • AbbVie’s blockbuster-in-waiting for endometriosis gets FDA nod AbbVie’s blockbuster-in-waiting for endometriosis gets FDA nod

    AbbVie’ s blockbuster-in-waiting for endometriosis gets FDA nod. AbbVie has scored a major new approval from the FDA, getting a green light yesterday for elagolix in endometriosis-related pain – ... Orilissa is billed as the first oral

  • US approval for first ever cannabis-based medicine US approval for first ever cannabis-based medicine

    Today’s approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies, ”said Justin ... GW Pharma has already filed with the FDA for a

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