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FDA’s Dry January: Little Novel Application Activity, But That Doesn’t Mean No Fun

 
• By Bridget Silverman

US FDA’s drugs center posted one of its lowest monthly approval counts of original applications in January, but new indications filled the gap, including new claims for Merck’s Keytruda, Takeda immunoglobulins, and Sanofi/Regeneron’s Dupixent.

Dry January
Sponsors better hope that FDA is not starting a new habit. • Source: Shutterstock

In contrast to the prodigious novel approval counts of 2023, the US FDA started the new year in a more abstemious fashion.

After approving Ligand Pharmaceuticals, Inc.’s new molecular entity Zelsuvmi (berdazimer gel) for molluscum contagiosum on 5 January 2024, only...

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