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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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A drug for autoimmune disease Sjögren's syndrome, claimed by Novartis when it bought MorphoSys, could soon be filed for approval.

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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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Boehringer Ingelheim's bid to return to the oncology arena has been achieved with an FDA approval for lung cancer therapy Hernexeos.

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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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Patients in England with rare eye disorder LHON will finally get access to a Chiesi drug that has been available in the rest of the UK for years.