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Keeping Track: US FDA Novel Approvals Return With Xenpozyme, Spevigo Nods; Stimufend Survives COVID-19 Delays

 
• By Bridget Silverman

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Keeping Track Feature image

The dog days of summer look to be over at the US FDA, as the Center for Drug Evaluation and Research ended an 11-week drought in novel agent approvals on 31 August 2022 with the approval of Sanofi’s Xenpozyme, followed the next day by a nod for Boehringer Ingelheim GmbH’s Spevigo.

The two approvals bring CDER’s novel agent count for 2022 to 18. At the same point last year, CDER had approved 36 novel agents.

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