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Keeping Track: FDA Hands Out Complete Responses, Expedited Pathway Designations

 
• By Michael Cipriano

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

The US FDA ran hot and cold for sponsors this week. Here's your news in brief. Mylan NV is the latest to sponsor of a Neulasta (pegfilgrastim) biosimilar to strikeout at FDA, becoming the fourth company to receive a complete response letter (CRL) for a copycat candidate.

AcelRx Pharmaceuticals Inc. also ran into an agency stop sign with a CRL for its acute pain opioid Dsuvia...

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