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FDA gives orphan drug status to Avidity’s rare muscular dystrophy treatment

There are currently no approved treatments for patients living with the disease

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Sandoz’s biosimilar denosumab application accepted by FDA for osteoporosis

More than ten million adults in the US alone over the age of 50 are estimated to have the condition

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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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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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AstraZeneca and Avillion’s asthma rescue treatment granted FDA approval

Airsupra significantly reduces the risk of severe asthma exacerbations

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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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