pharma news

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FDA approves its first 'national priority' drug – a version of the widely used antibiotic Augmentin XR – in double-quick time.

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The FDA could make it harder for developers of CAR-T therapies to bring them to market by requiring full randomised controlled trials.

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The FDA has qualified the first AI-based tool that can be used in clinical trials involving patients with MASH to help measure disease activity.

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Eli Lilly has revealed the data it hopes will take BTK inhibitor Jaypirca into frontline use for chronic lymphocytic leukaemia.

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The first cell therapy for severe aplastic anaemia – Gamida Cell's Omisirge – has been approved by the FDA.

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Gilead's Kite unit has showcased three new CAR-T therapies at ASH, headed by multiple myeloma candidate anito-cel, which could launch next year.