FDA Issues Boxed Warning on Elevidys (delandistrogene moxeparvovec‑rokl) – Use Limited to Ambulatory DMD Patients Aged 4+
The U.S. Food and Drug Administration (FDA) announced a Boxed Warning for Elevidys, Sarepta Therapeutics’...
Sarepta Therapeutics
FDA Clears Elevidys Gene Therapy After Investigating 8-Year-Old Boy’s Death
The U.S. Food and Drug Administration (FDA) has completed its investigation into the death of...
Sarepta Therapeutics Announces 500 Employee Layoffs After FDA Elevidys Trial Suspension
US-based Sarepta Therapeutics, a subsidiary of Sanofi (NASDAQ: SNY), announced the layoff of approximately 500...
Sarepta and Roche Seek to Resume Elevidys Trials After EMA Halt
The European Medicines Agency (EMA) may lift the temporary hold on certain Phase III studies...
Arrowhead and Sarepta Seal $11.38 Billion Global Licensing Deal for Rare Disease Treatments
US-based companies Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) and Sarepta Therapeutics (NASDAQ: SRPT) have announced a...
Roche’s Gene Therapy Elevidys Misses Primary Endpoint in DMD Trial
Switzerland-headquartered pharmaceutical giant Roche (SWX: ROG) has announced that a Phase III trial for its...
Sarepta Therapeutics’ Elevidys Receives FDA Accelerated Approval for Duchenne Muscular Dystrophy
US-based Sarepta Therapeutics, Inc. (NASDAQ: SRPT) has announced that the U.S. Food and Drug Administration...