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FDA Finally Approves First Ever Treatment Drug – Finally!
100 days after the FDA's legally mandated decision date,the FDA announced accelerated approval for Eteplirsen by Sarepta Therapeutics. Eteplirsen is the first therapy drug approved for Duchenne which works to skip...
FDA – NOT FOR DUCHENNE
April 26, 2016 As I sit bleary-eyed on the airplane flying home from what should have been a “successful” trip to DC, I am still stunned and disheartened from yesterday after a grueling TWELVE HOUR meeting with...
Clinical Trial – Day 1
I guess you can say - "we are lucky.' After 5 days of putting Alexander through extensive testing (a 3 hour MRI, extensive bloodwork, ECG, Pulmonary, 2 days of physical therapy assessment, fecal testing (ek!) and a...
