The U.S. Food and Drug Administration (FDA) on Tuesday approved dosing in Sarepta Therapeutics Inc.’s (NASDAQ: SRPT) Cohort 8 of ENDEAVOR (Study 9001-103). • SRPT shares are advancing steadily. Get ...
Wedbush upgrades Sarepta Therapeutics, citing overdone selloff and potential upside as FDA could re-approval Elevidys for non ...
Approximately 25 non-ambulatory participants will receive sirolimus as part of the regimen in Cohort 8 of the ENDEAVOR study, which is expected to begin before the end of the year The enhanced ...
The FDA now limits Elevidys to walking boys ages 4 and up after two teens died from liver failure The therapy will now carry a boxed warning for serious liver injury, liver failure and death Doctors ...
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Food and Drug Administration (FDA ...
MONDAY, Nov. 17, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) is tightening restrictions on a gene therapy used to treat Duchenne muscular dystrophy after two teenagers died ...
A new class of life-saving drugs is helping children who once had no hope. But some carry a price tag of millions for a ...
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Sarepta Wins FDA Approval To Begin Study On Reducing Liver Injury Risk With Elevidys
Sarepta Therapeutics, Inc. (SRPT) on Tuesday said that the U.S. Food and Drug Administration (FDA) has approved dosing in a study cohort to evaluate the use of an immunosuppressive regimen as part of ...
For the scientific enterprise, 2025 was marked by setbacks and challenges. But scientists are no strangers to adversity—the ability to overcome obstacles is built into our training. In turn, research ...
Sarepta Therapeutics SRPT announced that the FDA has approved significant changes to the label of Elevidys, its one-shot gene therapy for Duchenne muscular dystrophy (DMD). The revised labeling not ...
Sarepta has received US Food and Drug Administration (FDA) approval for updated prescribing information for Elevidys (delandistrogene moxeparvovec), an adeno-associated virus (AAV)-based gene transfer ...
Capricor Therapeutics’ stock has soared by more than 370% after a pivotal trial of its Duchenne muscular dystrophy (DMD) cell ...
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