All Dr Vinay Prasad articles
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NewsVinay Prasad to exit CBER as FDA group director
US agency is set to see another new face take the helm, following Dr Prasad’s departure at the end of April.
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NewsFDA policy sets new clinical trial requirements for drug approvals
The default standard would see US drug and biologic approvals require a single, robust pivotal study plus confirmatory evidence, instead of two trials.
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NewsGamida Cell wins cell therapy first in severe aplastic anaemia from FDA
The US approval for the Ayrmid company’s novel transplant option Omisirge adds to its existing licence in haematological malignancy.
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NewsBristol Myers Squibb wins fifth US approval for CAR T cell therapy Breyanzi
The FDA’s latest authorisation makes it the most widely approved of any CD19-directed CAR T therapy in cancer.