regulatory

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An oral alternative to injectable treatment for uncomplicated gonorrhoea could be on the way in the US, as FDA starts review of GSK's gepotidacin.

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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.

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More details have emerged of a UK plan for new medicines to get simultaneous decisions from the MHRA and NICE on their use by the NHS.

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Medical groups critical of the direction of vaccine policy in the US are being excluded from the recommendation-setting process.