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    FDA approves first gene therapy for Wiskott-Aldrich syndrome

    Symptoms of the rare disease include bleeding, eczema and frequent infections

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    FDA launches TEMPO digital health pilot

    Digital technologies can improve remote patient care for those with chronic diseases

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    Richard Pazdur, FDA’s drug evaluation chief, to leave FDA just weeks into new role

    Pazdur was previously head of the FDA’s Oncology Center of Excellence

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    Merck KGaA given FDA Fast Track designation for generalised myasthenia gravis drug

    Cladribine capsules could become the first ever oral treatment for gMG

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    Johnson & Jonson secures FDA approval for multiple myeloma treatment

    Support for first and only high-risk smouldering multiple myeloma treatment came from positive phase 3 trial results

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    GSK’s Blenrep approved by FDA for multiple myeloma

    Approval supported by positive results from phase 3 trial

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    Corcept Therapeutics reports positive phase 3 results in ovarian cancer treatment

    The company also plans to expand its phase 2 BELLA study to include three new study arms

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    MHRA and FDA expand collaboration on AI and medtech regulation

    National Commission on the Regulation of AI in Healthcare brings together UK and US experts

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    Roche’s small cell lung cancer therapy approved by FDA

    This is the first and only approved combination therapy for extensive-stage small cell lung cancer

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    Eli Lilly’s Inluriyo approved by FDA for breast cancer

    The oral drug can be used to treat advanced or metastatic breast cancer

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    FDA accepts supplemental New Drug Application for Pharming’s paediatric immunodeficiency therapy

    If approved, the treatment would be the first for children with APDS under 12 years

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    Invivyd working with FDA towards potential Biologics License Application for COVID-19

    The company plans head-to-head safety evaluation with COVID-19 vaccine, pending regulatory alignment

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