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FDA slaps clinical hold on BioMarin's PKU gene therapy

BioMarin Pharma has had another setback in its gene therapy development programme, announcing this morning that the FDA has placed a phase 1/2 trial of its candidate for phenylketonuria (PK

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FDA firms up JAK inhibitor warnings after Xeljanz review

The FDA has concluded its safety review of Pfizer's JAK inhibitor Xeljanz and Xeljanz XR, requiring revised warnings for the drugs as well as others in the class after finding evidence of e

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More trouble for Astellas as AT132 gene therapy trial is hal...

Astellas has halted dosing in a study of its AT132 gene therapy for the rare disease X-linked myotubular myopathy (XLMTM) for the second time after another serious adverse event (SAE) linke

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AZ says second COVID jab dose isn't linked to rare clot reac...

A new analysis has suggested that the rare blood clot side effects linked to AstraZeneca's COVID-19 vaccine Vaxzevria don't occur after a second dose.

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AZ, J&J tweaking COVID shots to reduce clotting risks; repor...

AstraZeneca and Johnson & Johnson are both exploring ways to modify their COVID-19 vaccines to minimise the risk of severe blood clotting reactions that are seen – albeit rarely – in so

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FDA adds warning of rare neurological side effect to J&J COV...

The FDA has added a new warning on the Johnson & Johnson COVID-19 vaccine, saying the shot has been linked to a serious but rare side effect – Guillain-Barré syndrome – that can cause m