Bridget Silverman
Senior Editor
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Latest From Bridget Silverman
Keeping Track: 2021’s First Novel Approvals Go To HIV And Heart Failure Therapies Opdivo Starts Year With A Bang
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
US FDA’s Median Review Time For Novel Drugs Held Steady In 2020
Even in the grip of the pandemic, review times for priority drugs were also consistent with the last three years.
Breakthroughs, Orphans Hit High Notes As US FDA’s 2020 Novel Approvals Play A Familiar Tune
Influence of expedited review pathways and regulatory incentives is on display in 2020’s novel approvals, which have a composition reassuringly consistent with recent years.
Keeping Track: Submissions Galore Start The New Year; US FDA Clears New Indications For Enhertu, Xalkori
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker
US FDA 2020 Novel Approval Count Rises To 53 At CDER, Plus 5 New CBER Biologics
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.