FDA

Market Access

FDA Commissioner Dr Martin Makary took the stage at BIO 2025 to detail the way he and his team have been challenging “deeply held assumptions”.

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Top FDA officials have spelled out their strategic priorities in the coming years, including the use of AI to "increase efficiency."

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The FDA has rolled out its highly-touted generative AI tool, almost a month early, with a promise to reduce the time taken for regulatory reviews.

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Stealth BioTherapeutics' filing for Barth syndrome therapy elamipretide has been turned down by the FDA, but there may be a way forward for the drug.

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MSD and Daiichi Sankyo suffer another setback with their HER3 programme ahead of a crucial data readout at ASCO.

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The FDA has instructed Pfizer and Moderna to add stronger warnings to the labels of their COVID-19 vaccines about the risk of cardiotoxicity.