gene therapies

News

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

News

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

Sanofi has been granted a speedy review from the FDA for a gene therapy for geographic atrophy, a major cause of blindness.

News

The FDA has launched a formal investigation into two liver failure-related deaths in patients treated with Duchenne gene therapy Elevidys.

News

Another death from liver failure has been seen with Roche and Sarepta's Duchenne muscular dystrophy therapy Elevidys, prompting a pause on treatment.