FDA

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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.

News

There is enough experience with the first wave of autologous CAR-T therapies to allow strict rules ensuring their safe use to be relaxed, says FDA.

R&D