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GSK immunotherapy

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GSK’s Benlysta given orphan drug status by FDA for systemic sclerosis

The rare autoimmune disease affects two to ten people per million and has limited treatments

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Tidepool’s automated insulin dosing app for type 1 diabetes gets FDA approval

Tidepool Loop is the first app of its kind to receive clearance in the US

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BeiGene’s Brukinsa receives FDA approval for chronic lymphocytic leukaemia

The BTK inhibitor demonstrated better results than Imbruvica, a standard of care treatment in CLL

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Eli Lilly’s Alzheimer’s drug denied FDA accelerated approval

The FDA said there was not enough trial data from patients who were treated for at least a year

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Genentech reports positive phase 3 data for its Tecentriq combination in liver cancer

Tecentriq in combination with Avastin significantly improved recurrence-free survival

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Novo Nordisk’s type 2 diabetes drug approved by FDA as first-line option

Rybelsus was initially approved in 2019 as a second-line treatment

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FDA and CDC investigate potential safety concern for Pfizer/BioNTech’s COVID-19 vaccine

Preliminary data showed a possible link between the updated vaccine and a higher risk of stroke

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Roche’s influenza medicine approved by EC for children

Xofluza is now the first single-dose, oral influenza medicine approved in Europe for children

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AstraZeneca and Avillion’s asthma rescue treatment granted FDA approval

Airsupra significantly reduces the risk of severe asthma exacerbations

Biogen Idec building

Biogen and Eisai’s Alzheimer’s drug receives FDA accelerated approval

An application has also been submitted for US approval under the traditional pathway

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GSK and CureVac to advance mRNA COVID-19 and flu vaccine candidates

The vaccines produced promising preliminary results in phase 1 trials

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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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