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Høeg’s appointment to director of CDER follows a turbulent period for the department, which recently saw the retirement of former head, Richard Padzur.
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The decision broadens Jaypirca’s label and converts the December 2023 accelerated approval to a traditional approval status.
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The UK government has also pledged to double the portion of GDP that it allocates to innovative drugs, from 0.3% to 0.6%, over the next ten years.
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The agreement includes upfront payments, sales and regulatory milestones.
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If Padzur retires, he would become one of several high-ranking FDA officials who left the agency in 2025.
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New non-primate draft guidance follows the agency’s wider aim to curtail the use of animal testing in preclinical toxicology.
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