FDA

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Will Gottlieb follow up on Trump's promise of a bonfire of regulations?

Industry group says FDA botched COVID-19 convalescent plasma...

Already under fire for what some view as a premature authorisation of convalescent plasma for COVID-19, the FDA is now being accused of a blunder that could render current supp

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COVID plasma treatment gets emergency license from FDA after...

The FDA has allowed a blood plasma treatment for COVID-19 to be administered under an Emergency Use license – but some have decried the move as a “political stunt” as president Trump accuses the

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BioMarin files achondroplasia drug after rejection for haemo...

US biotech BioMarin has hit back with a filing for a rare disease drug, after suffering what was described by analysts as a “major setback” when the FDA rejected its gene therapy for haemop

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AZ aims to cut cancer clinic visits with new Imfinzi regimen

The FDA is to review data supporting AstraZeneca’s Imfinzi (durvalumab) cancer immunotherapy in a new four-week regimen that will halve the number of required clinic visits for patients wit

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Regeneron’s cholesterol drug evinacumab claims February FDA ...

The FDA has started a speedy review of Regeneron’s ANGPTL3-targeting antibody evinacumab for a rare, inherited disorder that dramatically raises the risk of heart disease.<

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