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Keeping Track: A Burst of CRLs and BTDs, A Busy Week Of Submissions And Another Approval For Soliris

 
• By Michael Cipriano

The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track Feature image

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.

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