FDA

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FDA won't back Lilly's PD-1 antibody based on Chinese data a...

The FDA has dropped a bomb on Eli Lilly's marketing application for cancer immunotherapy sintilimab ahead of an advisory committee meeting due to take place on Thursday.

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Sanofi claims FDA okay for drug to treat rare blood disorder...

Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for the rare blood disorder in the US.

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Califf pledges not to use 'revolving door' between FDA and i...

Robert Califf has made a series of commitments to try to win over senators reluctant to back his nomination as the next FDA commissioner, ahead of the deciding vote on his appointment.

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FDA stifles Merck's cough drug gefapixant, asking for more d...

The FDA has issued a complete response letter (CRL) to Merck & Co's gefapixant candidate for refractory chronic cough, delaying the programme and giving Bayer an opportunity to close th

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FDA clears Gilead's Veklury for COVID outpatients

The FDA has extended the emergency use authorisation for Gilead Sciences' antiviral Veklury to include non-hospitalised patients with COVID-19, extending the uses of the drug.

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