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FDA approves two cell-based gene therapies for sickle cell disease

Vertex/CRISPR and bluebird bio’s gene therapies have been approved to treat patients aged 12 years and older

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bluebird bio presents positive results for inherited blood disorder gene therapies

The company’s sickle cell disease therapy was accepted for FDA priority review earlier this year

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bluebird bio to sell FDA priority review voucher for $103m

The company previously sold its second voucher to Bristol Myers Squibb for $95m

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bluebird bio’s sickle cell gene therapy accepted for FDA priority review

The genetic disease affects approximately 100,000 people in the US

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bluebird bio submits US application for sickle cell gene therapy

The genetic disease affects approximately 100,000 people in the US alone

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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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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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