FDA

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A court has ordered the FDA to revisit a decision to turn down a drug for jet lag developed by Vanda, potentially setting a crucial legal precedent.

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A leaked version of the Make America Healthy Again programme for the Trump administration has plenty for the pharma industry to stew over.

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Precigen has won approval in the US for a first-in-class immunotherapy for recurrent respiratory papillomatosis, Papzimeos, its first product.

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The FDA has added a warning label to bluebird bio's Skysona, after launching a probe into cases of blood cancer linked to the gene therapy.

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In a new spin on the concept of the FDA's 'revolving door', Vinay Prasad is back as head of CBER, just over a week after leaving the role.

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The FDA has launched a programme to make it easier to set up manufacturing facilities in the US and reduce the country's reliance on imported drugs.