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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.

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FDA clears new, safer regimen for Lilly's Alzheimer's drug

Eli Lilly has won FDA approval for a new regimen for its Alzheimer's disease therapy Kisunla, which carries a reduced risk of side effects.

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FDA loosens restrictions on first-gen CAR-T therapies

There is enough experience with the first wave of autologous CAR-T therapies to allow strict rules ensuring their safe use to be relaxed, says FDA.

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MHRA's chief safety officer, Dr Alison Cave

UK probes link between GLP-1 drugs and pancreatitis

The UK is studying cases of pancreatitis in people taking GLP-1 drugs for weight loss or type 2 diabetes to see if genetics may make them vulnerable.

Sarepta resists as FDA seeks pause on Elevidys use

Third death reported with a Sarepta gene therapy

EVERSANA unveils new AI-powered pharmacovigilance suite

FDA clears new, safer regimen for Lilly's Alzheimer's drug

FDA loosens restrictions on first-gen CAR-T therapies

UK probes link between GLP-1 drugs and pancreatitis

LSX2026: On promise and patience, with Hans Schambye

Using AI-driven synthetic personas to take your insights fur...

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