FDA

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The FDA seems to have won its staring contest with Sarepta over shipments of Elevidys, as the company blinks and agrees to a pause from today.

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The FDA has rounded out its senior leadership by naming biopharma industry executive George Tidmarsh to the role of CDER director.

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Sarepta has defied an FDA request to halt all use of its gene therapy for Duchenne muscular dystrophy, creating an intriguing regulatory impasse.

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FDA advisors have voted that the benefit/risk profile of GSK's multiple myeloma therapy, Blenrep, does not support its approval in the US.

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Federal staffers voice their anger and disgust as thousands of the Trump administration's reduction-in-force job losses are finalised.

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The FDA says publishing complete response letters for medicines is an act of "radical transparency," but it is not as revolutionary as it seems.