Here's your US drug development and review news in brief: PTC Therapeutics Inc. unsurprisingly ran into a US FDA stop sign for its Duchene muscular dystrophy (DMD) drug Translarna (ataluren), as the company received a complete response letter (CRL) after forcing the agency to review the new drug application (NDA) over protest.
Antares Pharma Inc. also landed a CRL for its testosterone enanthate injection Xyosted.