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FDA rejects Teva’s high-potency biosimilar of Humira again

Teva and partner Alvotech’s hopes of launching their biosimilar of AbbVie’s high-potency formulation of big-selling immunology drug Humira have been dashed, after the FDA

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FDA won’t approve Lilly’s mirikizumab for ulcerative colitis

The FDA has issued a complete response letter to Eli Lilly, turning down its attempt to get approval for anti-IL-23p19 antibody mirikizumab as a treatment for ulcerative c

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Ghana first country to approve Oxford malaria vaccine

A malaria vaccine developed by members of the University of Oxford team that created the AstraZeneca COVID-19 jab has been approved in its first market, Ghana.

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ICER backs sickle cell gene therapies at one-off cost of $2m

The influential Institute for Clinical and Economic Review (ICER) in the US has issued draft guidance suggesting that new gene therapies for sickle cell disease (SCD) from

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Appeals court keeps abortion pill available, for now

A federal appeals court has ruled that abortion drug mifepristone can remain available, but has blocked the drug from being sent to patients in the mail, along with other

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FDA advisors will look at full Leqembi approval in June

The FDA has convened a meeting of an advisory committee in June to consider the bid by Eisai and Biogen to convert their accelerated approval of Alzheimer’s disease therap

FDA rejects Teva’s high-potency biosimilar of Humira again

FDA won’t approve Lilly’s mirikizumab for ulcerative colitis

Ghana first country to approve Oxford malaria vaccine

ICER backs sickle cell gene therapies at one-off cost of $2m

Appeals court keeps abortion pill available, for now

FDA advisors will look at full Leqembi approval in June

NHS study will pick apart mental illness with data science

How to meet your physicians where they are online

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