Key Takeaways
- Metabolic and endocrine drugs have a higher than usual presence on the December user fee calendar, led by novel agents from Ionis and Neurocrine and new uses for Mirum's Chenodal, Lexicon's sotagliflozin and Lilly's Zepbound.
- Decisions on PD-1/L1 inhibitors also are expected for Checkpoint's novel candidate cosibelimab, a subcutaneous version of BMS' Opdivo, and new claims for AstraZeneca's Imfinzi and BeiGene's Tevimbra.
- Seven novel agents have December 2024 goal dates, including three candidates that have breakthrough therapy designations.
US Food and Drug Administration approval decisions for endocrine and metabolic disease therapies will crescendo through the rest of 2024, and could briefly make more noise than the perpetually dominant...
The FDA’s December 2024 user fee calendar features almost 20 goal dates, including seven new molecular entities and novel biologics, the Pink Sheet US FDA Performance Tracker’s
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