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Nine PDUFA dates on FDA’s December calendar
Ionis’ first wholly owned product among three rare disease therapies up for approval. BMS expecting decision on subcutaneous Opdivo
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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