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    • fulranumab

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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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    Pfizer’s Hympavzi significantly reduces bleeds in haemophilia patients

    Over 800,000 people worldwide live with haemophilia

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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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    Regeneron’s Libtayo receives EC approval for skin cancer

    Phase 3 trial results showed the drug significantly improved disease-free survival

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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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    Pfizer’s PADCEV gets FDA approval for bladder cancer

    Bladder cancer affects more than 614,000 people globally each year

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    Amgen reports positive results from landmark cardiovascular study

    The study found significant reductions of major cardiovascular events in high-risk adults following treatment

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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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    Pfizer and Metsera agree on merger after bidding war between Pfizer and Novo Nordisk

    The Pfizer bid was chosen by Metsera after a concern was raised about US antitrust laws regarding the Novo Nordisk offer

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    GSK’s Blenrep approved by FDA for multiple myeloma

    Approval supported by positive results from phase 3 trial

    - PMLiVE

    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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