DATA GRAPHICS | Data Byte
Ionis’ first wholly owned product among three rare disease therapies up for approval. BMS expecting decision on subcutaneous Opdivo
By Selina Koch, Executive, Editor, and Gunjan Ohri, Data Content Analyst
December 4, 2024 1:51 AM UTC
FDA has set target action dates for at least nine applications this month, including three for rare diseases and one for a subcutaneous formulation of Opdivo.
The first rare disease therapy up for approval in December is olezarsen, a POCIII-targeting antisense therapy from Ionis Pharmaceuticals Inc. (NASDAQ:IONS). Thirty-five years after the biotech’s founding, an approval of the therapy would complete Ionis’ transformation to an independent commercial company. …
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- Source: https://www.biocentury.com/article/654374/nine-pdufa-dates-on-fda-s-december-calendar