Particle News: Latest Sarepta Therapeutics news

FDA Brings Back Vinay Prasad to Lead Biologics Unit After Brief Exit

His reinstatement underlines tensions as political influence clashes with regulatory independence at the agency’s biologics center.

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FDA Lifts Hold on Elevidys Shipments to Ambulatory Duchenne Patients

Sarepta Temporarily Halts Elevidys Shipments Under FDA Request

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

Vinay Prasad Resigns as FDA Biologics Director After Politicized Tenure

Regulators Halt Elevidys Gene Therapy Worldwide After Safety Failures

FDA Flags Possible License Revocation for Sarepta’s Elevidys

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

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

Sarepta Defies FDA, Keeps Duchenne Gene Therapy on the Market