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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.

Orphan drugs dominate FDA's record-breaking year

Orphan drugs dominate FDA's record-breaking year

As 2019 gets under way, the pharma industry and the US FDA can look back at a truly record-breaking 2018 for new drug approvals. ... The FDA approved 46 drugs in 2017, which had itself matched a 2015 record, but last year saw a further surge in new

Latest news

  • Shire bags US approval for constipation drug Motegrity Shire bags US approval for constipation drug Motegrity

    It has the same mechanism as Trulance (plecanatide), which was approved by the FDA to treat CIC in January 2017 and brought in around $32m in the same period. ... therapy Cinryze, and has also just had a positive verdict for Takhzyro (lanadelumab) for

  • 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

  • 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

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