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Rybelsus

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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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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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California sues largest US insulin manufacturers and PBMs for overpricing

Eli Lilly, Novo Nordisk and Sanofi produce over 90% of the global insulin supply

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Oramed’s oral insulin candidate fails to meet phase 3 targets

The company said it expects to end its oral insulin clinical activities for type 2 diabetes

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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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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 first drug to delay onset of type 1 diabetes

Provention Bio’s Tzield delayed the average onset of type 1 diabetes by over four years

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FDA approves Seagen’s Adcetris combination for paediatric patients with Hodgkin lymphoma

Patients had a 59% reduction in the risk of disease progression or relapse, second cancer or death

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