Safety

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FDA restricts use of bluebird's Skysona gene therapy

The FDA has added a warning label to bluebird bio's Skysona, after launching a probe into cases of blood cancer linked to the gene therapy.

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FDA gives the go-ahead to restart Elevidys shipments

Sarepta has restarted distribution of its Duchenne muscular dystrophy gene therapy Elevidys, but only for patients who can walk.

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Sarepta backs down and pauses Elevidys shipments

The FDA seems to have won its staring contest with Sarepta over shipments of Elevidys, as the company blinks and agrees to a pause from today.

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A woman holds her hands up in a signal of 'No'

Sarepta resists as FDA seeks pause on Elevidys use

Sarepta has defied an FDA request to halt all use of its gene therapy for Duchenne muscular dystrophy, creating an intriguing regulatory impasse.

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Third death reported with a Sarepta gene therapy

A third fatality has been recorded among patients receiving treatment with a Sarepta gene therapy, adding to the troubles being faced by the company.

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Colleagues discuss information on a laptop screen

EVERSANA unveils new AI-powered pharmacovigilance suite

EVERSANA has launched a new pharmacovigilance platform to answer the need for advanced analytics and AI in drug safety monitoring and risk management.

FDA restricts use of bluebird's Skysona gene therapy

FDA gives the go-ahead to restart Elevidys shipments

Sarepta backs down and pauses Elevidys shipments

Sarepta resists as FDA seeks pause on Elevidys use

Third death reported with a Sarepta gene therapy

EVERSANA unveils new AI-powered pharmacovigilance suite

NHS staff 'feel unprepared for digital transformation'

How to meet your physicians where they are online

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