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FDA pens stinging report on Emergent COVID vaccine plant

Emergent BioSolutions' difficult month has been made worse by an FDA report into its facility in Baltimore, which has been blamed for the wastage of millions of doses of Johnson & Johns

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Romark eyes FDA okay for COVID antiviral despite mixed trial...

A phase 3 trial of Romark's antiviral drug NT-300 has missed the main objective in a phase 3 trial in mild to moderate COVID-19 patients, but could still have a shot at emergency use author

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Update: J&J COVID vaccine rollout paused as clot concerns sp...

US health authorities have recommended pausing dosing with Johnson & Johnson's COVID-19 vaccine as they investigate cases of blood clots also observed in some people taking the AstraZen

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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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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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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.

FDA pens stinging report on Emergent COVID vaccine plant

Romark eyes FDA okay for COVID antiviral despite mixed trial...

Update: J&J COVID vaccine rollout paused as clot concerns sp...

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

Acadia puts blame on FDA as Nuplazid rejected for dementia

FDA green lights Oxehealth vital signs monitoring software

GBL joins CVC in €10.7bn takeover bid for Recordati

Discover a new era of healthcare panel engagement: Grounded ...

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