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Keeping Track: US FDA Drugs Center Passes 50 Novel Agent Approvals In 2023

 
• By Bridget Silverman

AstraZeneca’s Truqap and Evive’s Ryzneuta bring FDA center for drugs’ 2023 novel agent total to 51, while biologics center already sits on a record-breaking 14 novel approvals.

50th cake
• Source: Shutterstock

By a matter of minutes, Evive Biotech’s long-delayed long-acting G-CSF Ryzneuta (efbemalenograstim alfa-vuxw) became the 50th novel agent approved in 2023 by the US FDA’s Center for Drug Evaluation and Research – a psychologically potent marker that has only been met three times over the past decade even during an extended approval boom.

The Ryzneuta approval letter was signed at 3:41 pm on 16 November 2023 by CDER Office of Cardiology, Hematology, Endocrinology

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