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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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FDA approves BMS’s Opdualag for metastatic or unresectable melanoma

The new, first-in-class fixed-dose dual immunotherapy combination treatment is administered as a single intravenous infusion

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