Actualités

Fierce Pharma5 j

FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault

In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...
BioSpace5 j

Sarepta Denies Latest Patient Death is Elevidys-Linked as FDA Launches Probe

Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe ...

FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths

Sarepta Therapeutics Inc. said another patient has died from acute liver failure after receiving one of its gene therapies, putting additional pressure on the biotech company after the recent deaths ...

Sarepta can begin shipping Elevidys therapy after FDA reverses pause, stock soars

Sarepta will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug Administration ...

FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...
Chemistry World3 j

Sarepta gene therapy deaths highlight tragic rare disease dilemma

Regulators block Duchenne muscular dystrophy treatment after fatal side-effects outweigh questionable efficacy ...
Pharmaceutical Technology via MSN4 j

Sarepta allowed to continue US Elevidys shipments

It has been a tumultuous two weeks for Sarepta; however, the FDA reauthorising US shipments of Elevidys will be a welcome ...
Fierce Pharma12 j

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

As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...

Sarepta will resume gene therapy shipments after FDA review of recent patient death

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...
BioSpace11 j

Sarepta Concedes to FDA Request, Suspends US Shipments of Elevidys

After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...

FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...