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A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
The commercial and clinical use of Elevidys was discontinued after two fatal cases of acute liver failure.
In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...
The company said it was “surprised” by the decision, which followed the ouster of multiple cell and gene therapy officials from the agency during deramiocel’s review.
Sarepta is facing a shareholder lawsuit over ELEVIDYS-related deaths. Robbins LLP cites safety risks and stock losses.
Sarepta's stock drops on ELEVIDYS safety concerns, yet potential remains for ambulatory patients. Click here to read an analysis of SRPT stock now.
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today provided a safety update regarding ELEVIDYS (dela ...
Following a second patient death, Sarepta is temporarily suspending use of Elevidys in non-ambulatory DMD patients, pending evaluation of an enhanced immunosuppression regimen.
Sarepta Therapeutics shares sank to their lowest level in nine years Monday after a second patient taking its Elevidys drug ...
The commercial and clinical use of Elevidys was discontinued after two fatal cases of acute liver failure.
TAS-205 showed no significant impact on motor function in patients with Duchenne muscular dystrophy (DMD), highlighting the ongoing search for effective treatments for the rare condition.
FDA is investigating Sarepta's Elevidys after two deaths from liver failure in non-ambulatory DMD patients, raising safety and regulatory concerns.
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