Safety

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Takeda halts trial of orexin drug in narcolepsy on safety gr...

Japanese drugmaker Takeda has suspended dosing in phase 2 trials of its orexin agonist TAK-994, saying it had encountered a "safety signal" in the study.

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Astellas reports fourth death in halted gene therapy trial

There has been a fourth patient fatality in Astellas' clinical trial of its AT132 gene therapy for the rare disease X-linked myotubular myopathy (XLMTM), which has been halted twice due to

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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.

Takeda halts trial of orexin drug in narcolepsy on safety gr...

Astellas reports fourth death in halted gene therapy trial

FDA slaps clinical hold on BioMarin's PKU gene therapy

FDA firms up JAK inhibitor warnings after Xeljanz review

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

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

Alzheimer's biotech Korsana to go public via reverse merger

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