Trump’s FDA Cuts Are Putting Drug Development at Risk
New SEC filings from pharmaceutical companies reveal Donald Trump and Elon Musk’s cost-cutting measures could slow drug ...
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FDA nominee pitches AI application review
In particular, AI could assist FDA staff to review drug and device applications, he told senators on the Health, Education, Labor and Pensions Committee. He was quick to add that AI would assist ...
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FDA accepts Sobi’s Gamifant application for HLH/MAS treatment
The application, which seeks approval for use in both adult and paediatric individuals who show an insufficient response or are not tolerant to glucocorticoids, or with recurrent MAS, has received ...