The US FDA’s Nifty Fifty
FDA has approved over 50 new molecular entities in a year for the second time – a truly remarkable job amid a global pandemic. But will 2021 be a tougher year?
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Wall Street is worried that a cluster of recent negative regulatory events means tougher reviews going forward. That concern is probably overdone, but a year into the COVID pandemic is a good time to take stock of how FDA is doing.
Gilead's Veklury for the treatment of COVID-19 was a clear commercial standout among new drugs in 2020, but cancer drugs like Seagen's Padcev and Tukysa are poised for long-term potential.
FDA reviewers stuck to established assessment practices during the coronavirus crisis and produced one of the agency’s largest yearly novel approval counts ever.