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

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