regulatory

Oncology

Radiopharmaceutical development must move beyond fixed paradigms toward patient-specific, data-driven optimisation.

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In another effort to boost domestic drug manufacturing, the FDA is piloting fast-track reviews for generics tested and made in US facilities.

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Rocket Pharma has withdrawn a filing in the US for its experimental gene therapy for Fanconi anaemia, but may consider partnering the programme.

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The FDA has cleared another generic of the abortion pill mifepristone, as it carries out a review of the drug that has been criticised as spurious.

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A pioneer of in vivo cell therapy, Umoja has cleared another regulatory milestone by getting fast-track status for its lead blood cancer programme.

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The Trump administration's linking of autism to Tylenol and vaccines with no evidence raises concern about an FDA review of mifepristone's safety.