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counterfeits

- PMLiVE

MHRA grants two new marketing authorisations for UCB’s inflammatory disease drug

Bimzelx is now approved to treat psoriatic arthritis and axial spondyloarthritis

- PMLiVE

Research shows new scientific technique could halve polio detection times

The new method could reduce costs and detection times for public health authorities

- PMLiVE

MHRA authorises HIPRA Human Health’s COVID-19 vaccine for use in UK

Bimervax is the ninth COVID-19 vaccine to be authorised by the UK medicines regulator

- PMLiVE

GSK’s Jemperli made available to endometrial cancer patients via UK’s early access scheme

Approximately 10,000 new cases of endometrial cancer are reported each year in the UK

- PMLiVE

MHRA to introduce new UK clinical trials framework

The changes will aim to make it easier to gain approval and to run clinical trials in the UK

- PMLiVE

Takeda’s dengue vaccine receives MHRA approval for those aged four years and older

Around 3.9 billion people globally are currently at risk of dengue, a mosquito-borne viral disease

- PMLiVE

BeiGene’s Brukinsa granted two new marketing authorisations by MHRA

The BTK inhibitor is now approved for chronic lymphocytic leukaemia and marginal zone lymphoma

- PMLiVE

bluebird bio sells second FDA priority review voucher for $95m

The company sold its first voucher to Dutch biotech Argenx for $102m

- PMLiVE

FDA approves Ferring’s Adstiladrin as first gene therapy for bladder cancer

Non-muscle-invasive bladder cancer represents around 75% of all new bladder cancer cases

- PMLiVE

Roche’s COVID-19 antibody receives FDA approval for hospitalised adults

The decision makes Actemra the first FDA-approved monoclonal antibody to treat COVID-19

- PMLiVE

FDA lifts partial clinical hold on bluebird bio’s sickle cell gene therapy studies

The company can now resume the enrolment and treatment of patients aged two to 17 years

- PMLiVE

MHRA set to receive nearly £1m from BEIS’ Regulator’s Pioneer Fund

Funding will aid three projects aiming to harness digital, data and scientific regulatory innovation

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