FDA Finds Fault With Third Duchenne Muscular Dystrophy Drug Filing
PTC Therapeutics receives refuse to file letter from FDA for its DMD drug Translarna; agency says NDA is 'not sufficiently complete' to permit substantive review.
PTC Therapeutics receives refuse to file letter from FDA for its DMD drug Translarna; agency says NDA is 'not sufficiently complete' to permit substantive review.