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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.

Astellas, Catalyst approvals set up record year for FDA approvals

Astellas, Catalyst approvals set up record year for FDA approvals

2018 is already well ahead of last year's tally. 2018 is shaping up to be an extraordinary year for novel drug approvals by the FDA, with another pair yesterday taking ... 2018 nine in front of last year’s total – which was the highest level for more

Latest news

  • Loxo, Bayer get FDA okay for biomarker-driven cancer drug Loxo, Bayer get FDA okay for biomarker-driven cancer drug

    A first for Loxo, and a second mutation-based targeted drug. Loxo Oncology has its first product approval, becoming the second company to get FDA backing for a drug that treats ... The FDA’s approval of Vikrakvi is for NKTR fusion-positive tumours

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

    Gamifant (emapalumab) – an antibody which neutralises interferon gamma - has been cleared by the FDA for primary haemophagocytic lymphohistiocytosis (HLH), an orphan disease characterised by widespread destruction of blood cells, extremely high

  • 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

    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 as ... 8th October 2018.

  • 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 as a ... Dacomitinib will be sold in the US as Vizimpro, and has been

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