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canagliflozin

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Biogen and Eisai announce FDA submission for early Alzheimer’s treatment

The licence application for the treatment of mild cognitive impairment due to Alzheimer’s disease was made as part of the accelerated approval pathway programme

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AstraZeneca’s Imfinzi plus chemotherapy accepted for Priority Review in the US

The drug combination offers biliary tract cancer patients a new treatment option

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FDA limits use of Janssen’s COVID-19 vaccine

Authorisation of Janssen COVID-19 vaccine restricted among certain people following analysis and evaluation

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FDA grants Prothena fast-track designation for next-generation Alzheimer’s disease therapy

Approximately 50 million people worldwide are estimated to be living with Alzheimer’s disease or other dementias

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FDA approves Alexion’s Ultomiris for generalised myasthenia gravis

gMG is a rare autoimmune neuromuscular disease that causes a loss of muscle function and severe weakness

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FDA approves COVID-19 treatment for those under the age of 12

Veklury is currently the only COVID-19 treatment approved for this age group

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Kite’s new CAR T-cell therapy manufacturing facility given the go-ahead by the FDA

The site in the US will produce CAR T-cell therapies for patients with blood cancers

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Enhertu to provide patients with vital targeted therapy option

Therapy receives FDA priority review as patients with HER2-mutant metastatic non-small cell lung cancer seek alternative treatment

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FDA delays Merck’s pneumococcal vaccine Vaxneuvance

It is predicted that the vaccine could make over $1bn in peak sales

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FDA grants Pfizer/BioNTech expanded EUA for an additional COVID-19 vaccine booster

The second booster authorisation is for those aged 50 years and older to promote high levels of protection against COVID-19 in the most vulnerable groups

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FDA approves Novartis’ Pluvicto for prostate cancer

The treatment is the first FDA approved targeted radioligand therapy for mCRPC patients

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Pfizer receives Breakthrough Therapy Designation from FDA for RSV vaccine candidate

There are currently no preventative, therapeutic or vaccine options for older adults diagnosed with RSV

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