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safinamide

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AbbVie’s Parkinson’s disease therapy application rejected by FDA

The regulator has requested more information on the pump used to administer ABBV-95

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

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

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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

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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

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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

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CHMP recommends use of Moderna’s Omicron BA.1 booster in children in the EU

The company is also evaluating the use of the vaccine in children aged from six months

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Sanofi/ Regeneron’s Dupixent recommended by CHMP to treat eosinophilic oesophagitis

Patients in a phase 3 trial experienced improvements in their ability to swallow after four weeks

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Eisai and Washington University to develop neurodegenerative disease therapies

Alzheimer’s will be a central focus for the new drug discovery collaboration

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FDA approves updated COVID-19 boosters for children aged from six months

The Moderna and Pfizer/BioNTech boosters both target the BA.4/BA.5 omicron subvariants

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Pfizer’s RSV vaccine candidate accepted for FDA priority review for use in older adults

A phase 3 study showed the vaccine was 85.7% effective in those with three or more symptoms

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Pfizer/BioNTech submit FDA application for BA.4/BA.5 COVID-19 vaccine in children under five

The vaccine is already authorised as a booster for ages five years and older in the US and EU

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FDA approves Rigel’s Rezlidhia for acute myeloid leukaemia

Phase 2 data showed a complete remission rate of 35% and median duration of 25.9 months

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