Particle News: Latest Delandistrogene moxeparvovec news

First Death Reported from Sarepta's Duchenne Gene Therapy Raises Safety Concerns

Sarepta Therapeutics confirms the death of a 16-year-old patient from acute liver failure linked to Elevidys, prompting updates to prescribing information and a significant stock decline.

4 ARTICLES

3w ago

George Tidmarsh Takes Helm at FDA Biologics Center, Stoking Independence Concerns

27 ARTICLES

2w ago

Vinay Prasad Resigns as FDA Biologics Director After Politicized Tenure

3 ARTICLES

3mo ago

AAN Highlights Gaps in Evidence for FDA-Approved Gene Therapy for Duchenne Muscular Dystrophy

3 ARTICLES

last mo.

FDA Investigates Fatal Liver Failures Linked to Sarepta’s Elevidys Therapy

13 ARTICLES

6d ago

FDA Reinstates Dr. Vinay Prasad as Biologics Chief Less Than Two Weeks After Resignation

12 ARTICLES

2w ago

FDA Lifts Hold on Elevidys Shipments to Ambulatory Duchenne Patients

7 ARTICLES

3w ago

Sarepta Defies FDA, Keeps Duchenne Gene Therapy on the Market

Particle.news

Delandistrogene moxeparvovec

Drug

First Death Reported from Sarepta's Duchenne Gene Therapy Raises Safety Concerns

FDA Flags Possible License Revocation for Sarepta’s Elevidys

Sarepta Shares Plummet on FDA Review of Elevidys Following Third Patient Death

Sarepta Temporarily Halts Elevidys Shipments Under FDA Request

Regulators Halt Elevidys Gene Therapy Worldwide After Safety Failures

George Tidmarsh Takes Helm at FDA Biologics Center, Stoking Independence Concerns

Vinay Prasad Resigns as FDA Biologics Director After Politicized Tenure

AAN Highlights Gaps in Evidence for FDA-Approved Gene Therapy for Duchenne Muscular Dystrophy

FDA Investigates Fatal Liver Failures Linked to Sarepta’s Elevidys Therapy

FDA Reinstates Dr. Vinay Prasad as Biologics Chief Less Than Two Weeks After Resignation

FDA Lifts Hold on Elevidys Shipments to Ambulatory Duchenne Patients

Sarepta Defies FDA, Keeps Duchenne Gene Therapy on the Market