Sarepta Elevidys Shipment Controversy

News

Sarepta, FDA and Elevidys

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 disorder who can walk, after the FDA recommended the removal of a voluntary hold that was placed on the therapy.

BioPharma Dive · 5h

FDA allows Sarepta to resume some Elevidys shipments

Fierce Pharma · 7d

Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market

Sarepta Therapeutics stock sinks further Tuesday after halting shipment of bestselling drug Elevidys

Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...

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 ...

7don MSN

Sarepta Therapeutics stock sinks after FDA tells company to stop shipping its bestselling drug

Sarepta Therapeutics' (SRPT) stock continued to sink Monday, down about 5% in early trade, following a rough end to last week ...

FiercePharma1mon

2nd patient dies after Sarepta's DMD gene therapy Elevidys

A second patient has died following treatment with Sarepta Therapeutics’ Elevidys, raising more doubts about the Duchenne muscular dystrophy (DMD) gene therapy’s safety profile. Sarepta and ...

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, ...

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