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BioPharma Dive5h

FDA allows Sarepta to resume some Elevidys shipments

The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...

FDA partially lifts hold on Sarepta's Duchenne gene therapy after community outcry

The FDA has partially reversed course on its push to halt shipments of a controversial gene therapy made by Sarepta ...

Sarepta resumes shipping of gene therapy Elevidys to patients who can walk

Sarepta Therapeutics said on Monday it will resume shipping of its gene therapy Elevidys to patients with a rare muscular ...

Sarepta falls as FDA plans to investigate death of child who received Elevidys

The U.S. Food and Drug Administration said on Friday that it is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics ( NASDAQ: SRPT) gene therapy for Duchenne ...
BioSpace3d

Sarepta Fallout Continues With EU’s Negative Opinion of Elevidys in Ambulatory Patients

The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...
MIT Technology Review3d

The deadly saga of the controversial gene therapy Elevidys

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.
BioSpace6d

Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle

Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, ...