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Daiichi and AZ pull Dato-DXd filing with FDA and try again

Nine months after filing their TROP2-directed antibody-drug conjugate Dato-DXd for a lung cancer indication with the FDA, Daiichi Sankyo and AstraZeneca have pulled the submission.

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Chasing $80bn sales target, AZ unveils $3.5bn US investment

AstraZeneca plans to invest a whopping $3.5 billion to expand its R&D and manufacturing operations in the US by 2026, as part of a drive to raise its revenues to $80 billion by the end

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Unicycive eyes June FDA verdict for hyperphosphataemia drug

The FDA has started a review of Unicycive Therapeutics' drug for hyperphosphataemia in patients with chronic kidney disease (CKD) who need dialysis, which hopes to improve on 'onerous' phos

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Autolus bags FDA approval for leukaemia cell therapy

Autolus has picked up its first product approval, getting an FDA green light for Aucatzyl as a treatment for patients with aggressive blood cancer acute lymphoblastic leukaemia (ALL).

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Eisai dials back forecasts for Alzheimer's drug Leqembi

Eisai has retreated from the optimistic view of sales growth for Alzheimer's disease drug Leqembi it held earlier this year as uptake remains sluggish.

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AZ confirms China president has been detained

AstraZeneca has revealed that its top executive in China, Leon Wang, has been detained by Chinese authorities, after confirming he was under investigation last week.

Daiichi and AZ pull Dato-DXd filing with FDA and try again

Chasing $80bn sales target, AZ unveils $3.5bn US investment

Unicycive eyes June FDA verdict for hyperphosphataemia drug

Autolus bags FDA approval for leukaemia cell therapy

Eisai dials back forecasts for Alzheimer's drug Leqembi

AZ confirms China president has been detained

Biotech is back, with Craig Ackerman

Using AI-driven synthetic personas to take your insights fur...

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