CBER's Regulatory Activity in 2018: A Reading List
The US FDA's biologics center invested heavily in preparation for coming waves of advanced therapies.
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FDA reviewers stuck to established assessment practices during the coronavirus crisis and produced one of the agency’s largest yearly novel approval counts ever.
Spironolactone TOPCAT Regional Analysis Falls Short At US FDA AdComm, But Hospitalizations Drive Vote
A new indication for the generic diuretic in heart failure with preserved ejection fraction gets an 8-4 vote, with one abstention, despite troubles an analysis that tries to revive the TOPCAT trial with an analysis excluding Eastern European sites – or about half the participants.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.