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As 2024 Begins, US FDA’s Novel Agent Prospects Look A Lot Like 2023

 
• By Bridget Silverman

Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.

pills in mirror
FDA could see a reflection of its 2023 reviews in this year’s class. • Source: Shutterstock

The US FDA’s user fee calendar for 2024 already features almost 60 new molecular entities and novel biologics, echoing the agency’s review workload at the beginning of 2023 – a position that contains the prospect of another blockbuster year for new drugs and biologics ahead, given the record-breaking 72 novel approvals issued last year.

Just three therapeutic categories – oncology, hematology and neuroscience – accounted for over half of the US FDA’s 2023 new molecular entity and novel biologic approvals

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