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What Pandemic Effect? US FDA’s 2021 Approval Class Is Off To Strong Start With 60+ Novel Candidates

 
• By Bridget Silverman

Dermatology, chronic kidney disease and liver disease therapies stand out in a crowd of user fee goals that is actually bigger than at the same point in 2020.

High corn crops on a row
The US FDA may have a bumper crop of new drug approvals this year.

With more than 60 novel drug and biologic candidates already under review, the potential class of 2021 has bursts of activity in therapy areas that have been quiet in recent years – notably dermatology and liver and kidney disease – alongside a full pipeline in recent stalwarts like oncology and neurology.

Remarkably, 2021 is starting out with more novel agents under review than at the same point in early 2020 –...

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Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
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Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
• By Eliza Slawther

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Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

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