Keeping Track: Novartis, Calardius Pick Up Speed; ADMA Stumbles

 
• By Michael Cipriano
  
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The latest drug development news and highlights from our FDA Performance Tracker.

FDA shows no signs of going on summer vacation, with another active week of approvals and helpful suggestions. And the agency delivered a bit of bad news in an area that could signal growing concern for manufacturers: ADMA Biologics Inc. has become the third drugmaker in as many weeks to land a quality-related complete response letter, with FDA rejecting its primary humoral immunodeficiency disease candidate RI-002.

Following years of court battles, Natco Pharma Ltd.has finally won FDA for the first version of generic Tamiflu after...

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