FDA is investigating Sarepta's Elevidys after two deaths from liver failure in non-ambulatory DMD patients, raising safety ...

In one of the first major tests of the new FDA leadership’s regulatory philosophy toward gene therapies for rare diseases, ...

The FDA is assessing the need for “further regulatory action” on Sarepta's Duchenne muscular dystrophy gene therapy in the ...

Sarepta stock dropped again Wednesday — extending a steep dive this year — after the Food and Drug Administration announced that it's investigating the deaths of two patients who received Sarepta ...

The FDA said yesterday that it is investigating the deaths from liver failure of two non-ambulatory boys with Duchenne ...

Elevidys has been given full approval to treat ambulatory patients with DMD, with an accelerated approval in non-ambulatory ...

Sarepta Therapeutics Inc. misled investors about the safety and prospects for one of its Duchenne muscular dystrophy ...

The FDA is investigating two deaths in non-ambulatory Duchenne muscular dystrophy patients who received a Sarepta gene ...

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Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of ...

A second case of acute liver failure resulting in death has been reported in nonambulatory DMD patients treated with Elevidys.