The latest drug development news and highlights from our US FDA Performance Tracker.
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.
The Council of the EU has made several key amendments to the legislative reform package, which it will now negotiate with the European Parliament.
The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.
The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
