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Provention faces delay in FDA review of diabetes prevention ...

The FDA says it has uncovered "deficiencies" in the marketing application for Provention Bio's much-anticipated drug teplizumab for the prevention of

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FDA green lights Oxehealth vital signs monitoring software

UK digital health company Oxehealth has claimed FDA approval for software that can be used to remotely measure vital signs like heart and breathing rates from a camera feed.

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Acadia puts blame on FDA as Nuplazid rejected for dementia

Acadia Pharmaceuticals is butting heads with US regulators again, this time over the FDA’s decision to reject its Nuplazid (pimavanserin) for use in dementia-related psychosis (DRP) – with the c

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