After serious side effect, Sarepta and FDA realign on next-gen Duchenne drug with trial hold lifted

After serious side effect, Sarepta and FDA realign on next-gen Duchenne drug with trial hold lifted

Source: 
Endpoints
snippet: 

FDA’s monthslong trial hold on Sarepta Therapeutics’ next-gen Duchenne muscular dystrophy drug is out the door after the biotech and regulator hashed out a new global trial protocol to expand monitoring of urine biomarkers.