News 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.
News 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.
News 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.
News FDA fast-tracks Sanofi's gene therapy for eye disease GA Sanofi has been granted a speedy review from the FDA for a gene therapy for geographic atrophy, a major cause of blindness.
News FDA probing deaths with DMD gene therapy Elevidys The FDA has launched a formal investigation into two liver failure-related deaths in patients treated with Duchenne gene therapy Elevidys.
News DMD gene therapy Elevidys linked to new liver failure case Another death from liver failure has been seen with Roche and Sarepta's Duchenne muscular dystrophy therapy Elevidys, prompting a pause on treatment.
News MFN model for Medicaid revealed by CMS The Trump administration has released details of a most-favoured nation (MFN) drug pricing programme for medicines provided by Medicaid.
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