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    • Sarepta Therapeutics

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    FDA unveils new voucher programme to accelerate drug review process

    The programme is designed to reduce the review time for companies supporting US national interests

    - PMLiVE

    FDA approves Bavarian Nordic’s chikungunya vaccine for individuals aged from 12 years

    The mosquito-borne viral disease has been reported across many popular travel destinations

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    Roche’s Evrysdi tablet formulation granted FDA approval for spinal muscular atrophy

    The progressive neuromuscular disease affects approximately one in every 10,000 babies globally

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    Roche/Sarepta announce two-year results for Duchenne muscular dystrophy gene therapy

    The muscle-wasting disorder is estimated to affect one in every 5,000 male births worldwide

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    FDA accepts updated protocol for Annovis’ phase 3 Alzheimer’s disease study

    The company hopes the revised protocol will accelerate the development timeline of buntanetap

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    MHRA approves Italfarmaco’s Duvyzat to treat Duchenne muscular dystrophy

    The severe neuromuscular disease affects approximately 2,500 people in the UK

    - PMLiVE

    NICE recommends Santhera’s Duchenne muscular dystrophy drug Agamree

    Approximately 1,700 patients with the muscle-wasting disorder in England are expected to benefit from the decision

    - PMLiVE

    FDA approves BridgeBio Pharma’s Attruby to treat rare heart disease ATTR-CM

    Transthyretin amyloid cardiomyopathy affects up to 500,000 people worldwide

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    UCB’s Bimzelx granted FDA approval to treat hidradenitis suppurativa in adults

    The inflammatory skin disease affects approximately one in every 100 people in the US

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    Novavax announces FDA clinical hold lift on phase 3 COVID-19/flu vaccine study

    The serious adverse event reported was found to be unrelated to the vaccine

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    FDA approves Autolus Therapeutics’ Aucatzyl to treat acute lymphoblastic leukaemia

    Approximately 8,400 adults are diagnosed with the aggressive blood cancer every year in the US and EU

    - PMLiVE

    FDA approves Journey Medical’s Emrosi to treat inflammatory lesions of rosacea

    The long-term skin condition affects more than 16 million people in the US

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