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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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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.

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

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

FDA loosens restrictions on first-gen CAR-T therapies

Novo sues Lilly over 'misleading' GLP-1 ad campaigning

Discover a new era of healthcare panel engagement: Grounded ...

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